A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol

July 28, 2023 updated by: Yangtze River Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Peking, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants who can understand and are willing to strictly follow the clinical trial protocol to complete the trial and sign the informed consent;
  2. Male participants aged 18~45 years (including the cut-off value);
  3. Weight≥50.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m^2 (including the critical value);
  4. Good health, no history of respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic diseases;
  5. Do not plan to have children during the trial, and agree to use reliable contraception during the trial and for 3 months after the last study drug administration, and do not plan to donate sperm.

Exclusion Criteria:

  1. Allergic: allergic to drugs, food, pollen, alcohol, etc., known to be allergic to experimental drugs or other PDE5 inhibitors and excipients;
  2. Patients with difficulty swallowing tablets/capsules; Or according to 0.5g/kg body weight intake of alcohol (that is, 70kg body weight participants drink 35g pure alcohol, equivalent to 50 degrees of liquor about 70g) may be intoxicated; Or have special dietary requirements and cannot accept the standard diet provided by the research center;
  3. Patients who have a history of needle fainting and blood fainting, can not tolerate venous puncture blood collection and/or have difficulty in blood collection;
  4. Patients with abnormal color vision judged by researchers to have clinical significance; Or have known to have retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION) eye disease; Or have known fundus medical history that other investigators have deemed unsuitable for inclusion;
  5. People who have experienced sudden hearing loss or hearing loss in the past;
  6. Past or existing postural hypotension/syncope;
  7. Clinically significant vital signs (reference value range: 90 mmHg≤systolic blood pressure (sitting) <140 mmHg, 60 mmHg≤diastolic blood pressure (sitting)<90 mmHg, 55 times/min≤pulse rate (resting)≤100 times/min, 35.5℃≤body temperature (axillary temperature)≤37.2℃; Participant to the judgment of the study physician); Or physical examination, 12-lead electrocardiogram, laboratory test results, the investigator judged that the abnormality is clinically significant;
  8. Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody any abnormal clinical significance;
  9. Those who have used soft drugs (such as cannabis) within 3 months before screening or hard drugs (such as cocaine, amphetamines, Phencyclidine, etc.) within 1 year before screening; Or have a history of drug abuse; Or positive urine drug screening before randomization;
  10. Positive breath test for alcohol;
  11. Smokers who have smoked more than 5 cigarettes per day in the 3 months before screening or could not stop using any tobacco products during the test;
  12. Participants in any clinical trial within 3 months prior to screening;
  13. Those who have participated in blood donation and total blood donation or total blood loss≥400mL within 3 months before screening, or participated in blood donation and total blood donation≥200mL or total blood loss≥200mL within 1 month; Or receiving blood transfusion; Or plan to donate blood within 1 month after the end of this trial;
  14. Those who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the trial;
  15. Those who have received vaccination within 30 days prior to screening, or who plan to receive vaccination during the trial;
  16. Use of any CYP3A4/5 inhibitors or inducers (e.g., inhibitors-itraconazole, fluconazole, clarithromycin, ritonavir, cimetidine, diltiazem, etc.) within 28 days prior to randomization; Inducers-rifampicin, phenobarbital, carbamazepine);
  17. Those who have taken any prescription drugs, non-prescription drugs, health products, vitamins, or Chinese herbs within 14 days before randomization;
  18. Those who have eaten grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before randomization;
  19. People who ingested beverages or foods rich in caffeine or xanthine (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before randomization;
  20. Patients who developed acute disease from the screening stage to before randomization;
  21. Participants judged by the investigator to be unsuitable for this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tunodafil Hydrochloride plus alcohol
Participants received 100 mg Tunodafil Hydrochloride Tablets plus 0.5 g/kg alcohol.
Drug: Tunodafil Hydrochloride Tablets
100mg Tunodafil Hydrochloride Tablets
Other: Alcohol
0.5 g/kg alcohol
Experimental: Placebo plus alcohol
Participants received placebo plus 0.5 g/kg alcohol.
Drug: Placebo
Placebo
Other: Alcohol
0.5 g/kg alcohol
Experimental: Tunodafil Hydrochloride
Participants received 100mg Tunodafil Hydrochloride Tablets.
Drug: Tunodafil Hydrochloride Tablets
100mg Tunodafil Hydrochloride Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum change in systolic blood pressure (SBP)
Time Frame: 4 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) SBP.
4 hours after treatment
Maximum change in diastolic blood pressure (DBP)
Time Frame: 4 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) DBP.
4 hours after treatment
Maximum change in pulse
Time Frame: 4 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) position.
4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine SBP
Time Frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine SBP relative to baseline change.
4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine DBP
Time Frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine DBP relative to baseline change.
4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of pulse
Time Frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of pulse relative to baseline change.
4 hours after treatment
Peak concentration (Cmax) of Tunodafil and metabolites M459
Time Frame: 24 hours after treatment
24 hours after treatment
Area under drug time curve (AUC) of Tunodafil and metabolites M459
Time Frame: 24 hours after treatment
24 hours after treatment
Peak concentration (Cmax) of alcohol
Time Frame: 8 hours after treatment
8 hours after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame: 7 days after treatment
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.
7 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yangtze River Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YZJ-YKNF-DDI-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunction

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings