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/NCT05976503</url>
    </required_header>
    <id_info>
      <org_study_id>YZJ-YKNF-DDI-08</org_study_id>
      <nct_id>NCT05976503</nct_id>
    </id_info>
    <brief_title>A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol</brief_title>
    <official_title>A Randomized, Blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Potential Interaction of Tunodafil Hydrochloride Tablets and Alcohol in Healthy Chinese Male Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yangtze River Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yangtze River Pharmaceutical Group Co., Ltd.</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 purpose of this study is primarily to evaluate the effects of simultaneous administration&#xD;
        of Tunodafil Hydrochloride Tablets with alcohol on blood pressure, pulse rate and&#xD;
        pharmacokinetics in healthy Chinese male participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be divided into two parts: pre-trial and formal trial. The pre-trial is a&#xD;
        non-randomized, open design to evaluate the safety and tolerability of Tunodafil&#xD;
        Hydrochloride Tablets in combination with alcohol in healthy male participants. Four&#xD;
        participants will be taken 50mg or 100mg doses with alcohol. Supine blood pressure (systolic&#xD;
        and diastolic), pulse rate, PK blood sample collection should be performed before and after&#xD;
        administration, and the time point is the same as the formal trial.&#xD;
  &#xD;
        The dosage of Tunodafil Hydrochloride Tablets in the formal trial will be determined based on&#xD;
        the pre-trial results.&#xD;
  &#xD;
        The formal trial is a single-center, randomized, blind, placebo-controlled, three-cycle&#xD;
        crossover design, and 18 participants will be randomized to receive the following three&#xD;
        treatments. The test is administered once per cycle and the washout period is 7 days:&#xD;
  &#xD;
        Treatment A: A single oral dose of Tunodafil Hydrochloride Tablets plus an oral dose of&#xD;
        alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).&#xD;
  &#xD;
        Treatment B: A single oral dose of placebo plus an oral dose of alcohol drink mixed with&#xD;
        fruit juice (0.5 g of absolute ethanol per kilogram of body weight).&#xD;
  &#xD;
        Treatment C: A single oral dose of Tunodafil Hydrochloride Tablets plus an oral dose of&#xD;
        placebo drink mixed with fruit juice.&#xD;
  &#xD;
        For each treatment period, supine blood pressure and pulse rate will be measured at pre-dose&#xD;
        and up to 24 hours post-dose. Blood will be collected at pre-dose and up to 24 hours&#xD;
        post-dose.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 19, 2022</start_date>
    <completion_date type="Actual">March 21, 2023</completion_date>
    <primary_completion_date type="Actual">March 8, 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>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum change in systolic blood pressure (SBP)</measure>
      <time_frame>4 hours after treatment</time_frame>
      <description>Maximum change from baseline in decubitus (semi-decubitus) SBP.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum change in diastolic blood pressure (DBP)</measure>
      <time_frame>4 hours after treatment</time_frame>
      <description>Maximum change from baseline in decubitus (semi-decubitus) DBP.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum change in pulse</measure>
      <time_frame>4 hours after treatment</time_frame>
      <description>Maximum change from baseline in decubitus (semi-decubitus) position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The area under effect-time curve (AUEC0- 4h) of supine SBP</measure>
      <time_frame>4 hours after treatment</time_frame>
      <description>The area under effect-time curve (AUEC0- 4h) of supine SBP relative to baseline change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The area under effect-time curve (AUEC0- 4h) of supine DBP</measure>
      <time_frame>4 hours after treatment</time_frame>
      <description>The area under effect-time curve (AUEC0- 4h) of supine DBP relative to baseline change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The area under effect-time curve (AUEC0- 4h) of pulse</measure>
      <time_frame>4 hours after treatment</time_frame>
      <description>The area under effect-time curve (AUEC0- 4h) of pulse relative to baseline change.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak concentration (Cmax) of Tunodafil and metabolites M459</measure>
      <time_frame>24 hours after treatment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under drug time curve (AUC) of Tunodafil and metabolites M459</measure>
      <time_frame>24 hours after treatment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak concentration (Cmax) of alcohol</measure>
      <time_frame>8 hours after treatment</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0</measure>
      <time_frame>7 days after treatment</time_frame>
      <description>A treatment-emergent adverse events (TEAE) is defined as any unfavorable and unintended sign,symptom or disease temporally associated with the use of a study drug.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">22</enrollment>
    <condition>Erectile Dysfunction</condition>
    <arm_group>
      <arm_group_label>Tunodafil Hydrochloride plus alcohol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received 100 mg Tunodafil Hydrochloride Tablets plus 0.5 g/kg alcohol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo plus alcohol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received placebo plus 0.5 g/kg alcohol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tunodafil Hydrochloride</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received 100mg Tunodafil Hydrochloride Tablets.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tunodafil Hydrochloride Tablets</intervention_name>
      <description>100mg Tunodafil Hydrochloride Tablets</description>
      <arm_group_label>Tunodafil Hydrochloride</arm_group_label>
      <arm_group_label>Tunodafil Hydrochloride plus alcohol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo plus alcohol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Alcohol</intervention_name>
      <description>0.5 g/kg alcohol</description>
      <arm_group_label>Placebo plus alcohol</arm_group_label>
      <arm_group_label>Tunodafil Hydrochloride plus alcohol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants who can understand and are willing to strictly follow the clinical trial&#xD;
               protocol to complete the trial and sign the informed consent;&#xD;
  &#xD;
            2. Male participants aged 18~45 years (including the cut-off value);&#xD;
  &#xD;
            3. Weight≥50.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m^2 (including the&#xD;
               critical value);&#xD;
  &#xD;
            4. Good health, no history of respiratory system, circulatory system, digestive system,&#xD;
               urinary system, blood system, endocrine system, immune system, nervous system, mental&#xD;
               system and other serious diseases or chronic diseases;&#xD;
  &#xD;
            5. Do not plan to have children during the trial, and agree to use reliable contraception&#xD;
               during the trial and for 3 months after the last study drug administration, and do not&#xD;
               plan to donate sperm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Allergic: allergic to drugs, food, pollen, alcohol, etc., known to be allergic to&#xD;
               experimental drugs or other PDE5 inhibitors and excipients;&#xD;
  &#xD;
            2. Patients with difficulty swallowing tablets/capsules; Or according to 0.5g/kg body&#xD;
               weight intake of alcohol (that is, 70kg body weight participants drink 35g pure&#xD;
               alcohol, equivalent to 50 degrees of liquor about 70g) may be intoxicated; Or have&#xD;
               special dietary requirements and cannot accept the standard diet provided by the&#xD;
               research center;&#xD;
  &#xD;
            3. Patients who have a history of needle fainting and blood fainting, can not tolerate&#xD;
               venous puncture blood collection and/or have difficulty in blood collection;&#xD;
  &#xD;
            4. Patients with abnormal color vision judged by researchers to have clinical&#xD;
               significance; Or have known to have retinitis pigmentosa, macular degeneration,&#xD;
               nonarteriotic anterior ischemic optic neuropathy (NAION) eye disease; Or have known&#xD;
               fundus medical history that other investigators have deemed unsuitable for inclusion;&#xD;
  &#xD;
            5. People who have experienced sudden hearing loss or hearing loss in the past;&#xD;
  &#xD;
            6. Past or existing postural hypotension/syncope;&#xD;
  &#xD;
            7. Clinically significant vital signs (reference value range: 90 mmHg≤systolic blood&#xD;
               pressure (sitting) &lt;140 mmHg, 60 mmHg≤diastolic blood pressure (sitting)&lt;90 mmHg, 55&#xD;
               times/min≤pulse rate (resting)≤100 times/min, 35.5℃≤body temperature (axillary&#xD;
               temperature)≤37.2℃; Participant to the judgment of the study physician); Or physical&#xD;
               examination, 12-lead electrocardiogram, laboratory test results, the investigator&#xD;
               judged that the abnormality is clinically significant;&#xD;
  &#xD;
            8. Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum&#xD;
               specific antibody, human immunodeficiency virus antibody any abnormal clinical&#xD;
               significance;&#xD;
  &#xD;
            9. Those who have used soft drugs (such as cannabis) within 3 months before screening or&#xD;
               hard drugs (such as cocaine, amphetamines, Phencyclidine, etc.) within 1 year before&#xD;
               screening; Or have a history of drug abuse; Or positive urine drug screening before&#xD;
               randomization;&#xD;
  &#xD;
           10. Positive breath test for alcohol;&#xD;
  &#xD;
           11. Smokers who have smoked more than 5 cigarettes per day in the 3 months before&#xD;
               screening or could not stop using any tobacco products during the test;&#xD;
  &#xD;
           12. Participants in any clinical trial within 3 months prior to screening;&#xD;
  &#xD;
           13. Those who have participated in blood donation and total blood donation or total blood&#xD;
               loss≥400mL within 3 months before screening, or participated in blood donation and&#xD;
               total blood donation≥200mL or total blood loss≥200mL within 1 month; Or receiving&#xD;
               blood transfusion; Or plan to donate blood within 1 month after the end of this trial;&#xD;
  &#xD;
           14. Those who have undergone surgery within 30 days prior to screening, or plan to undergo&#xD;
               surgery during the trial;&#xD;
  &#xD;
           15. Those who have received vaccination within 30 days prior to screening, or who plan to&#xD;
               receive vaccination during the trial;&#xD;
  &#xD;
           16. Use of any CYP3A4/5 inhibitors or inducers (e.g., inhibitors-itraconazole,&#xD;
               fluconazole, clarithromycin, ritonavir, cimetidine, diltiazem, etc.) within 28 days&#xD;
               prior to randomization; Inducers-rifampicin, phenobarbital, carbamazepine);&#xD;
  &#xD;
           17. Those who have taken any prescription drugs, non-prescription drugs, health products,&#xD;
               vitamins, or Chinese herbs within 14 days before randomization;&#xD;
  &#xD;
           18. Those who have eaten grapefruit, pomelo, dragon fruit, mango and other fruits or&#xD;
               related products that affect metabolic enzymes within 7 days before randomization;&#xD;
  &#xD;
           19. People who ingested beverages or foods rich in caffeine or xanthine (such as coffee,&#xD;
               strong tea, chocolate, cola, etc.) within 48 hours before randomization;&#xD;
  &#xD;
           20. Patients who developed acute disease from the screening stage to before randomization;&#xD;
  &#xD;
           21. Participants judged by the investigator to be unsuitable for this clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Sexes Eligible for the Study</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Peking University People's Hospital</name>
        <address>
          <city>Peking</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Erectile Dysfunction</mesh_term>
    </condition_browse>
    <!-- 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/NCT05976503
  org study id: YZJ-YKNF-DDI-08
  nct id: NCT05976503
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is primarily to evaluate the effects of simultaneous administration
        of Tunodafil Hydrochloride Tablets with alcohol on blood pressure, pulse rate and
        pharmacokinetics in healthy Chinese male participants.
  This study will be divided into two parts: pre-trial and formal trial. The pre-trial is a
        non-randomized, open design to evaluate the safety and tolerability of Tunodafil
        Hydrochloride Tablets in combination with alcohol in healthy male participants. Four
        participants will be taken 50mg or 100mg doses with alcohol. Supine blood pressure (systolic
        and diastolic), pulse rate, PK blood sample collection should be performed before and after
        administration, and the time point is the same as the formal trial.
  
        The dosage of Tunodafil Hydrochloride Tablets in the formal trial will be determined based on
        the pre-trial results.
  
        The formal trial is a single-center, randomized, blind, placebo-controlled, three-cycle
        crossover design, and 18 participants will be randomized to receive the following three
        treatments. The test is administered once per cycle and the washout period is 7 days:
  
        Treatment A: A single oral dose of Tunodafil Hydrochloride Tablets plus an oral dose of
        alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
  
        Treatment B: A single oral dose of placebo plus an oral dose of alcohol drink mixed with
        fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
  
        Treatment C: A single oral dose of Tunodafil Hydrochloride Tablets plus an oral dose of
        placebo drink mixed with fruit juice.
  
        For each treatment period, supine blood pressure and pulse rate will be measured at pre-dose
        and up to 24 hours post-dose. Blood will be collected at pre-dose and up to 24 hours
        post-dose.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Maximum change in systolic blood pressure (SBP)
  time frame: 4 hours after treatment
  description: Maximum change from baseline in decubitus (semi-decubitus) SBP.
  measure: Maximum change in diastolic blood pressure (DBP)
  time frame: 4 hours after treatment
  description: Maximum change from baseline in decubitus (semi-decubitus) DBP.
  measure: Maximum change in pulse
  time frame: 4 hours after treatment
  description: Maximum change from baseline in decubitus (semi-decubitus) position.
  measure: The area under effect-time curve (AUEC0- 4h) of supine SBP
  time frame: 4 hours after treatment
  description: The area under effect-time curve (AUEC0- 4h) of supine SBP relative to baseline change.
  measure: The area under effect-time curve (AUEC0- 4h) of supine DBP
  time frame: 4 hours after treatment
  description: The area under effect-time curve (AUEC0- 4h) of supine DBP relative to baseline change.
  measure: The area under effect-time curve (AUEC0- 4h) of pulse
  time frame: 4 hours after treatment
  description: The area under effect-time curve (AUEC0- 4h) of pulse relative to baseline change.
  measure: Peak concentration (Cmax) of Tunodafil and metabolites M459
  time frame: 24 hours after treatment
  measure: Area under drug time curve (AUC) of Tunodafil and metabolites M459
  time frame: 24 hours after treatment
  measure: Peak concentration (Cmax) of alcohol
  time frame: 8 hours after treatment
  measure: Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
  time frame: 7 days after treatment
  description: A treatment-emergent adverse events (TEAE) is defined as any unfavorable and unintended sign,symptom or disease temporally associated with the use of a study drug.
  arm group label: Tunodafil Hydrochloride plus alcohol
  arm group type: Experimental
  description: Participants received 100 mg Tunodafil Hydrochloride Tablets plus 0.5 g/kg alcohol.
  arm group label: Placebo plus alcohol
  arm group type: Experimental
  description: Participants received placebo plus 0.5 g/kg alcohol.
  arm group label: Tunodafil Hydrochloride
  arm group type: Experimental
  description: Participants received 100mg Tunodafil Hydrochloride Tablets.
  intervention type: Drug
  intervention name: Tunodafil Hydrochloride Tablets
  description: 100mg Tunodafil Hydrochloride Tablets
  arm group label: Tunodafil Hydrochloride
  arm group label: Tunodafil Hydrochloride plus alcohol
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo plus alcohol
  intervention type: Other
  intervention name: Alcohol
  description: 0.5 g/kg alcohol
  arm group label: Placebo plus alcohol
  arm group label: Tunodafil Hydrochloride plus alcohol
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Sexes Eligible for the Study
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Erectile Dysfunction