<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/NCT04467203</url>
  </required_header>
  <id_info>
    <org_study_id>5849-CPK-1002</org_study_id>
    <nct_id>NCT04467203</nct_id>
  </id_info>
  <brief_title>Evaluate the Effects of Food on the Pharmacokinetics of Fadanafil in Healthy Subjects</brief_title>
  <official_title>A Single Center, Randomized, Open-label, Two-period Crossover Phase 1b Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Oral Fadanafil Tablet in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sihuan Pharmaceutical Holdings Group Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sihuan Pharmaceutical Holdings Group Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics&#xD;
      of single oral fadanafil tablet 100mg in healthy subjects.&#xD;
&#xD;
      Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a&#xD;
      single center, randomized, open-label, two-period crossover study in approximately 14 Chinese&#xD;
      healthy adult male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2019</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 14, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Parameter AUC(0-24)</measure>
    <time_frame>Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours</time_frame>
    <description>AUC(0-24) of Fadanafile is area usder the curve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrocardiogram (ECG) QT interval Safety and tolerability</measure>
    <time_frame>Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours</time_frame>
    <description>To evaluate subject ECG QT interval Changing information</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fadanafil fast to fat meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Seven subjects in group A will receive treatment in the following order:&#xD;
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-&gt; At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fadanfil fat meal to fat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Seven subjects in group B will receive treatment in the following order:&#xD;
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-&gt; At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fadanafil</intervention_name>
    <description>Seven subjects in group A will receive treatment in the following order:&#xD;
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-&gt;&#xD;
At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order:&#xD;
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-&gt; At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting</description>
    <arm_group_label>Fadanafil fast to fat meal</arm_group_label>
    <arm_group_label>Fadanfil fat meal to fat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects 18-45 years old, inclusive.&#xD;
&#xD;
          -  Body weight ≥50kg and Body Mass Index: 19.0~26.0 kg/m2, inclusive&#xD;
&#xD;
          -  The vital signs (body temperature, systolic and diastolic blood pressure, heart rate&#xD;
             and respiration) were in the normal range, and the normal value range of each vital&#xD;
             sign was: (1) body temperature (underarm) 36.3 ~ 37.2 ℃; (2) 90mmHg ≤ systolic blood&#xD;
             pressure &lt; 140mmHg; (3) 60mmhg ≤ diastolic blood pressure &lt; 90mmHg; (4) 50th / min ≤&#xD;
             heart rate ≤ 90th / min.&#xD;
&#xD;
          -  Before the test, a comprehensive physical examination, laboratory examination and&#xD;
             other auxiliary examinations were carried out, and the results were normal or abnormal&#xD;
             but of no clinical significance. The ECG QTcF &lt; 450 ms.&#xD;
&#xD;
          -  Subjects should be willing to take appropriate contraceptive measures during the&#xD;
             period of taking the study drug and within 6 months after discontinuation to avoid&#xD;
             pregnancy of their partners.&#xD;
&#xD;
          -  Subjects understand and will comply with the study procedure, participated voluntarily&#xD;
             and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have a history of clinical significant drug allergy (especially those who&#xD;
             are known or suspected to have a history of allergy to any PDE-5 inhibitor or its&#xD;
             components) or a history of atopic allergic diseases (asthma, urticaria, eczema&#xD;
             dermatitis) or severe allergic constitution.&#xD;
&#xD;
          -  History of clinically significant ECG abnormality or family history of long QT&#xD;
             syndrome (grandparents, parents, brothers and sisters).&#xD;
&#xD;
          -  Subjects with severe systemic diseases, such as respiratory, blood, endocrine,&#xD;
             cardiovascular and cerebrovascular diseases or mental disorders.&#xD;
&#xD;
          -  Subjects with concominant diseases that may affect drug absorption, distribution,&#xD;
             metabolism, excretion and safety evaluation, or reduce compliance.&#xD;
&#xD;
          -  The test results of human immunodeficiency virus (HIV) antibody or hepatitis B surface&#xD;
             antigen (HBsAg) or hepatitis C virus (HCV) antibody or syphilis are positive.&#xD;
&#xD;
          -  Subjects who have used over-the-counter drugs, health products, Chinese herbal&#xD;
             medicine or traditional Chinese medicine within 2 weeks before screening, or who are&#xD;
             taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit&#xD;
             (except those who occasionally take paracetamol orally, but the total maximum dose&#xD;
             cannot exceed 1g, and the drug is not allowed to take orally within 48 hours prio to&#xD;
             first dose).&#xD;
&#xD;
          -  Subjects who had used any prescription drugs (especially CYP3A4 inhibitors, nitrates,&#xD;
             α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4&#xD;
             weeks before screening.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haiyan Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100076</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04467203
org study id: 5849-CPK-1002
nct id: NCT04467203
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effect of high fat meal on the pharmacokinetics
      of single oral fadanafil tablet 100mg in healthy subjects.

      Fadanafil is a selective phosphodiesterase (PDE5) inhibitor. The proposed Phase 1b trial is a
      single center, randomized, open-label, two-period crossover study in approximately 14 Chinese
      healthy adult male subjects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic Parameter AUC(0-24)
time frame: Pre dose and 0.25, 0.5, 0.75, 1,1.5,2,2.5,4,6,8,12,24,36 hours
description: AUC(0-24) of Fadanafile is area usder the curve
measure: Electrocardiogram (ECG) QT interval Safety and tolerability
time frame: Change from Baseline to 1, 2, 4, 6, 8, 12, 24 hours
description: To evaluate subject ECG QT interval Changing information
arm group label: Fadanafil fast to fat meal
arm group type: Experimental
description: Seven subjects in group A will receive treatment in the following order:
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting-> At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal
arm group label: Fadanfil fat meal to fat
arm group type: Experimental
description: Seven subjects in group B will receive treatment in the following order:
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting
intervention type: Drug
intervention name: Fadanafil
description: Seven subjects in group A will receive treatment in the following order:
At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting->
At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order:
At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting
arm group label: Fadanafil fast to fat meal
arm group label: Fadanfil fat meal to fat
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor