xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06015516</url>
    </required_header>
    <id_info>
      <org_study_id>P23112a</org_study_id>
      <secondary_id>2023-503796-14-00</secondary_id>
      <nct_id>NCT06015516</nct_id>
    </id_info>
    <brief_title>Bioavailability Clinical Trial of Oral Minoxidil 1 mg</brief_title>
    <official_title>Randomised, Crossover Bioavailability Clinical Trial of Oral Minoxidil 1 MG, After Single and Multiple Dose Administration to Healthy Volunteers Under Fasting Conditions.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Industrial Farmacéutica Cantabria, S.A.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Industrial Farmacéutica Cantabria, S.A.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of&#xD;
        the drug in the body) of a new oral formulation of minoxidil administered in healthy&#xD;
        volunteers.&#xD;
  &#xD;
        The main question that is to answer is to evaluate the bioavailability of the oral test&#xD;
        formulation of minoxidil. The secondary onjectives is to compare it with the formulation&#xD;
        already on the market (i.e . Regaxidil® 20 mg/mL cutaneous solution).&#xD;
  &#xD;
        It is planned that 14 healthy female volunteers of legal age (without any known pathology)&#xD;
        participate in the study. The expected duration of the study is approximately 23-56 days.&#xD;
  &#xD;
        Each volunteer that decide to participate in this study will be sequentially administered one&#xD;
        of the formulations planned for the study: either the test formulation (oral minoxidil&#xD;
        tablets of 1 mg, developed by Industrial Farmacéutica Cantabria, S.A.), or the reference&#xD;
        formulation (minoxidil skin solution, 20 mg/mL, marketed by Industrial Farmacéutica&#xD;
        Cantabria, S.A.). After five days of administration of one of the study formulations, at&#xD;
        least 7 days will elapse before starting an additional five days of administration of the&#xD;
        other study formulation that had not been administered in the first sequence. Assignment to&#xD;
        this sequence of administration of the study formulations (oral formulation or topical&#xD;
        solution) shall be completely randomised.&#xD;
  &#xD;
        In each of these sequential periods of five days of administration of the study formulations,&#xD;
        the concentration of minoxidil will be quantified in blood samples, which will be taken from&#xD;
        each of the volunteers at certain times after the administration of the medication. These&#xD;
        blood analyses will enable to determine the parameters that define the pharmacokinetic&#xD;
        profile of the new oral formulation under study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase I, oral multiple-dose, open-label, crossover and randomized clinical trial, 2&#xD;
        sequences, 2 periods, in which subjects will be hospitalized from 10 h before to 12 hours&#xD;
        after the first and fifth doses under fasting conditions in both periods.&#xD;
  &#xD;
        The study will be blinded only for the plasma concentrations determination of minoxidil.&#xD;
  &#xD;
        It is planned to include 14 healthy women volunteers, aged from 18 to 55 years old. The&#xD;
        overall duration of the study is estimated at 24-56 days, from recruitment of the volunteers&#xD;
        to the last examination.&#xD;
  &#xD;
        The test drug is minoxidil 1 mg tablets, manufactured by Industrial Farmacéutica Cantabria,&#xD;
        S.A. It will be administered a total of five 1 mg doses (once a day) per oral, under fasting&#xD;
        conditions. The reference drug is minoxidil 20 mg/ml (2%) topical solution, marketed in Spain&#xD;
        by Industrial Farmacéutica Cantabria, S.A., under the name the trade name of Regaxidil®. It&#xD;
        will be applied five 1 mL doses (once a day) topical route, under fasting conditions.&#xD;
  &#xD;
        Each one of the subjects will receive a daily dose during five days of minoxidil test or&#xD;
        reference in each one of the two periods according to the corresponding randomization&#xD;
        sequence, after at least 7 days washout period between each one of admission days.&#xD;
  &#xD;
        The main objective is to evaluate the relative bioavailability of the oral test formulation&#xD;
        of minoxidil 1 mg after single dose and multiple dose (at steady state). The bioavailability&#xD;
        of oral formulation will be evaluated from the AUC0-t and Cmax for single dose on the first&#xD;
        administration day and AUC(0-τ)SS, Cmax,ss and Cτ,ss on the steady state of minoxidil. Tmax&#xD;
        and Tmax,ss and fluctuation of minoxidil will be also calculated. All the pharmacokinetic&#xD;
        parameters will be calculated from the plasma concentrations of minoxidil of the formulation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Area Under the Curve From Time Zero to the last determination (AUC0-t and AUC(0-τ)ss) for minoxidil.</measure>
      <time_frame>Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.</time_frame>
      <description>According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum observed plasma concentration (Cmax and Cmax,ss) for minoxidil from time zero to the last determination at steady state (Cτ,ss).</measure>
      <time_frame>Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.</time_frame>
      <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.&#xD;
  According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area Under the Curve (AUC) for both minoxidil formulations.</measure>
      <time_frame>Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.</time_frame>
      <description>The relative bioavailability of the oral test formulation of minoxidil is obtained by analysing the AUC from plasma concentrations of both formulations of minoxidil (oral and topical solution) and then these will compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) and Peak Cmax steady state for both minoxidil formulations.</measure>
      <time_frame>Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.</time_frame>
      <description>The relative bioavailability of the oral test formulation of minoxidil is obtained by analysing the fhe peak concentration (Cmax and Cmax,ss) from plasma concentrations of both formulations of minoxidil (oral and topical solution) and then these will compared.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the safety and tolerability of oral minoxidil .</measure>
      <time_frame>Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.</time_frame>
      <description>The safety profile of oral minoxidil will be evaluated by analysing the incidence of adverse events of the oral test formulation compared the commercial formulation. The safety parameters will be expressed individually as mean values +/- standard deviation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Treatment Test: Oral minoxidil 1 mg tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be administered one tablet of oral minoxidil 1mg once a day, orally, after fasting for at least 10 hours, with 240 mL or 8 Oz. of water, and fasting for a further 5 hours.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be administered topically on the scalp after fasting for at least 10 hours pre-dose and 5 hours post-dose. After the administration subject should not wash her head for at least 5 hours. Each one mL dose of 2% topical minoxidil will be carefully measured to provide 20 mg of minoxidil using the syringe provided with each bottle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Minoxidil Tablets</intervention_name>
      <description>Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.&#xD;
  Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period.</description>
      <arm_group_label>Treatment Test: Oral minoxidil 1 mg tablets</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Minoxidil topical solution 20 mg/ml</intervention_name>
      <description>Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.&#xD;
  Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period.</description>
      <arm_group_label>Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Women, who after receiving information about the study design, the objectives, the&#xD;
               possible risks that could be derived from it and the fact that they can refuse to&#xD;
               collaborate at any time, give their written informed consent to participate in the&#xD;
               study.&#xD;
  &#xD;
            2. Aged from 18 to 55 years old.&#xD;
  &#xD;
            3. No clinically significant organic or psychic conditions.&#xD;
  &#xD;
            4. No clinically significant abnormalities in medical records and physical examination.&#xD;
  &#xD;
            5. No clinically significant abnormalities in haematology, coagulation, biochemistry,&#xD;
               serology (Ag HBs, HC antibodies, HIV antibodies) and urinalysis.&#xD;
  &#xD;
            6. No clinically significant abnormalities in vital signs and electrocardiogram.&#xD;
  &#xD;
            7. Women of child-bearing potential age women participating in the study will compromise&#xD;
               to use a high effective contraceptive method or will be abstinent during their&#xD;
               participation in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects affected by an organic or psychic condition. Before a volunteer is included,&#xD;
               all the safety parameters defined in points 7.3 will be considered. Those who present&#xD;
               clinically significant analytical alterations and in whom biochemical kidney and/or&#xD;
               liver damage markers are outside the normal range applied by the laboratory will be&#xD;
               excluded [GOT, GPT and/or GGT &gt;2.5*ULN and total bilirrubin &gt;1.5*ULN (total bilirrubin&#xD;
               &gt;1.5*ULN is acceptable if the direct bilirrubin is &lt;35%)].&#xD;
  &#xD;
            2. Subjects who have received prescribed pharmacological treatment in the last 15 days or&#xD;
               abstinent of medication in the 48 hours prior to receiving the study medication, but&#xD;
               women are allowed taking contraceptives. Contraceptive methods must be used at least 4&#xD;
               weeks prior to entry visit and not to be changed for the duration of the study.&#xD;
  &#xD;
            3. Subjects with body mass index (weight (kg)/height2 (m2)) outside the 18.5-30.0 range.&#xD;
  &#xD;
            4. History of sensitivity to any drug.&#xD;
  &#xD;
            5. Positive drug screening for cannabis, opiates, cocaine and amphetamines.&#xD;
  &#xD;
            6. Smoker.&#xD;
  &#xD;
            7. Daily consumers of alcohol and/or acute alcohol poisoning over the last week.&#xD;
  &#xD;
            8. Having donated blood in the last month before start of the study.&#xD;
  &#xD;
            9. Pregnant or breastfeeding women.&#xD;
  &#xD;
           10. Participation in another study with administration of investigational drugs in the&#xD;
               previous 3 months (if the study was conducted with drug substances marketed in Spain,&#xD;
               a period of at least 1 month or 5 half lives, what is longer, will be considered).&#xD;
  &#xD;
           11. Inability to follow the instructions or collaborate during the study.&#xD;
  &#xD;
           12. History of difficulty in swallowing&#xD;
  &#xD;
           13. Alterations on the scalp such as erythema, dryness or any other condition that at&#xD;
               investigator criteria could affect the absortion of the topical solution.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dolores Ochoa Mazarro</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clinical Trial Unit, Clinical Pharmacology Department Hospital Universitario de La Princesa (Madrid, Spain)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ana López-Ballesteros</last_name>
      <phone>+34671778847</phone>
      <email>ana.lopez@cantabrialabs.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maria Jose Gómez-Sánchez</last_name>
      <phone>+34647764688</phone>
      <email>mariajose.gomez@cantabrialabs.es</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Universitario de la Princesa</name>
        <address>
          <city>Madrid</city>
          <zip>28006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Dolores Ochoa Mazarro</last_name>
        <phone>+34915202247</phone>
        <email>dochoa@iis-princesa.org</email>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <link>
      <url>http://cima.aemps.es/cima/dochtml/ft/57597/FT_57597.html</url>
      <description>Summary of Product Characteristics (SmPC): Minoxidil 20 mg/ml solución cutánea</description>
    </link>
    <link>
      <url>http://cima.aemps.es/cima/dochtml/ft/55636/FT_55636.html</url>
      <description>Summary of Product Characteristics (SmPC): Minoxidil 10 mg tablets.</description>
    </link>
    <reference>
      <citation>Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.</citation>
      <PMID>14996087</PMID>
    </reference>
    <reference>
      <citation>Shamsaldeen OS, Al Mubki T, Shapiro J. Topical agents for hair growth promotion: what is out there? Skin Therapy Lett. 2013 Jun;18(4):5-7.</citation>
      <PMID>24310642</PMID>
    </reference>
    <reference>
      <citation>Vano-Galvan S, Pirmez R, Hermosa-Gelbard A, Moreno-Arrones OM, Saceda-Corralo D, Rodrigues-Barata R, Jimenez-Cauhe J, Koh WL, Poa JE, Jerjen R, Trindade de Carvalho L, John JM, Salas-Callo CI, Vincenzi C, Yin L, Lo-Sicco K, Waskiel-Burnat A, Starace M, Zamorano JL, Jaen-Olasolo P, Piraccini BM, Rudnicka L, Shapiro J, Tosti A, Sinclair R, Bhoyrul B. Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. J Am Acad Dermatol. 2021 Jun;84(6):1644-1651. doi: 10.1016/j.jaad.2021.02.054. Epub 2021 Feb 24.</citation>
      <PMID>33639244</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bioavailability</keyword>
    <keyword>Clinical trial</keyword>
    <keyword>minoxidil</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Minoxidil</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06015516
  org study id: P23112a
  secondary id: 2023-503796-14-00
  nct id: NCT06015516
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the pharmacokinetic profile (behaviour of
        the drug in the body) of a new oral formulation of minoxidil administered in healthy
        volunteers.
  
        The main question that is to answer is to evaluate the bioavailability of the oral test
        formulation of minoxidil. The secondary onjectives is to compare it with the formulation
        already on the market (i.e . Regaxidil® 20 mg/mL cutaneous solution).
  
        It is planned that 14 healthy female volunteers of legal age (without any known pathology)
        participate in the study. The expected duration of the study is approximately 23-56 days.
  
        Each volunteer that decide to participate in this study will be sequentially administered one
        of the formulations planned for the study: either the test formulation (oral minoxidil
        tablets of 1 mg, developed by Industrial Farmacéutica Cantabria, S.A.), or the reference
        formulation (minoxidil skin solution, 20 mg/mL, marketed by Industrial Farmacéutica
        Cantabria, S.A.). After five days of administration of one of the study formulations, at
        least 7 days will elapse before starting an additional five days of administration of the
        other study formulation that had not been administered in the first sequence. Assignment to
        this sequence of administration of the study formulations (oral formulation or topical
        solution) shall be completely randomised.
  
        In each of these sequential periods of five days of administration of the study formulations,
        the concentration of minoxidil will be quantified in blood samples, which will be taken from
        each of the volunteers at certain times after the administration of the medication. These
        blood analyses will enable to determine the parameters that define the pharmacokinetic
        profile of the new oral formulation under study.
  This is a phase I, oral multiple-dose, open-label, crossover and randomized clinical trial, 2
        sequences, 2 periods, in which subjects will be hospitalized from 10 h before to 12 hours
        after the first and fifth doses under fasting conditions in both periods.
  
        The study will be blinded only for the plasma concentrations determination of minoxidil.
  
        It is planned to include 14 healthy women volunteers, aged from 18 to 55 years old. The
        overall duration of the study is estimated at 24-56 days, from recruitment of the volunteers
        to the last examination.
  
        The test drug is minoxidil 1 mg tablets, manufactured by Industrial Farmacéutica Cantabria,
        S.A. It will be administered a total of five 1 mg doses (once a day) per oral, under fasting
        conditions. The reference drug is minoxidil 20 mg/ml (2%) topical solution, marketed in Spain
        by Industrial Farmacéutica Cantabria, S.A., under the name the trade name of Regaxidil®. It
        will be applied five 1 mL doses (once a day) topical route, under fasting conditions.
  
        Each one of the subjects will receive a daily dose during five days of minoxidil test or
        reference in each one of the two periods according to the corresponding randomization
        sequence, after at least 7 days washout period between each one of admission days.
  
        The main objective is to evaluate the relative bioavailability of the oral test formulation
        of minoxidil 1 mg after single dose and multiple dose (at steady state). The bioavailability
        of oral formulation will be evaluated from the AUC0-t and Cmax for single dose on the first
        administration day and AUC(0-τ)SS, Cmax,ss and Cτ,ss on the steady state of minoxidil. Tmax
        and Tmax,ss and fluctuation of minoxidil will be also calculated. All the pharmacokinetic
        parameters will be calculated from the plasma concentrations of minoxidil of the formulation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Area Under the Curve From Time Zero to the last determination (AUC0-t and AUC(0-τ)ss) for minoxidil.
  time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
  description: According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.
  measure: Maximum observed plasma concentration (Cmax and Cmax,ss) for minoxidil from time zero to the last determination at steady state (Cτ,ss).
  time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
  description: Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
  According to the recommendations of the regulatory authorities, for the analysis of the compared bioavailability of the formulations from single dose and under steady-state conditions, the primary endpoint will be the area under the curve during a dosage interval (AUC0-t and AUC(0-τ)ss) calculated using the linear trapezoidal method, maximum plasma concentration (Cmax and Cmax,ss) and concentration at the end of the dosing interval (Cτ,ss) at steady state calculated from the plasma concentrations of minoxidil.
  measure: Area Under the Curve (AUC) for both minoxidil formulations.
  time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
  description: The relative bioavailability of the oral test formulation of minoxidil is obtained by analysing the AUC from plasma concentrations of both formulations of minoxidil (oral and topical solution) and then these will compared.
  measure: Maximum Plasma Concentration (Cmax) and Peak Cmax steady state for both minoxidil formulations.
  time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
  description: The relative bioavailability of the oral test formulation of minoxidil is obtained by analysing the fhe peak concentration (Cmax and Cmax,ss) from plasma concentrations of both formulations of minoxidil (oral and topical solution) and then these will compared.
  measure: To evaluate the safety and tolerability of oral minoxidil .
  time frame: Day 0 (pre-dose) and at multiple time-points (up to day 5) post-dose.
  description: The safety profile of oral minoxidil will be evaluated by analysing the incidence of adverse events of the oral test formulation compared the commercial formulation. The safety parameters will be expressed individually as mean values +/- standard deviation.
  arm group label: Treatment Test: Oral minoxidil 1 mg tablets
  arm group type: Experimental
  description: Participants will be administered one tablet of oral minoxidil 1mg once a day, orally, after fasting for at least 10 hours, with 240 mL or 8 Oz. of water, and fasting for a further 5 hours.
  arm group label: Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution
  arm group type: Active Comparator
  description: Participants will be administered topically on the scalp after fasting for at least 10 hours pre-dose and 5 hours post-dose. After the administration subject should not wash her head for at least 5 hours. Each one mL dose of 2% topical minoxidil will be carefully measured to provide 20 mg of minoxidil using the syringe provided with each bottle.
  intervention type: Drug
  intervention name: Minoxidil Tablets
  description: Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.
  Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period.
  arm group label: Treatment Test: Oral minoxidil 1 mg tablets
  intervention type: Drug
  intervention name: Minoxidil topical solution 20 mg/ml
  description: Since oral minoxidil is a new formulation and, according to the recommendations of the Regulatory Authorities, it is considered appropriate to carry out a multiple dose study to evaluate and to compare the bioavailability between both formulations (oral versus topical solution), measuring the plasma concentrations of minoxidil.
  Achievement of steady-state is assessed by comparing at least three pre-dose concentrations for each formulation, as half-life of minoxidil is around 4 hours, we will administered 5 doses in each period.
  arm group label: Treatment Reference: Regaxidil 20 mg/ml (2%) topical solution
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dolores Ochoa Mazarro
  role: Principal Investigator
  affiliation: Clinical Trial Unit, Clinical Pharmacology Department Hospital Universitario de La Princesa (Madrid, Spain)
  last name: Ana López-Ballesteros
  phone: +34671778847
  email: ana.lopez@cantabrialabs.es
  last name: Maria Jose Gómez-Sánchez
  phone: +34647764688
  email: mariajose.gomez@cantabrialabs.es
  facility: 
  contact: 
  country: Spain
  url: http://cima.aemps.es/cima/dochtml/ft/57597/FT_57597.html
  description: Summary of Product Characteristics (SmPC): Minoxidil 20 mg/ml solución cutánea
  url: http://cima.aemps.es/cima/dochtml/ft/55636/FT_55636.html
  description: Summary of Product Characteristics (SmPC): Minoxidil 10 mg tablets.
  citation: Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.
  PMID: 14996087
  citation: Shamsaldeen OS, Al Mubki T, Shapiro J. Topical agents for hair growth promotion: what is out there? Skin Therapy Lett. 2013 Jun;18(4):5-7.
  PMID: 24310642
  citation: Vano-Galvan S, Pirmez R, Hermosa-Gelbard A, Moreno-Arrones OM, Saceda-Corralo D, Rodrigues-Barata R, Jimenez-Cauhe J, Koh WL, Poa JE, Jerjen R, Trindade de Carvalho L, John JM, Salas-Callo CI, Vincenzi C, Yin L, Lo-Sicco K, Waskiel-Burnat A, Starace M, Zamorano JL, Jaen-Olasolo P, Piraccini BM, Rudnicka L, Shapiro J, Tosti A, Sinclair R, Bhoyrul B. Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. J Am Acad Dermatol. 2021 Jun;84(6):1644-1651. doi: 10.1016/j.jaad.2021.02.054. Epub 2021 Feb 24.
  PMID: 33639244
  responsible party type: Sponsor
  mesh term: Minoxidil
  sharing ipd: No