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NCT05976503

A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol

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
Yangtze River Pharmaceutical Group Co., Ltd.·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Erectile Dysfunction
Drug/Device/Intervention
Tunodafil Hydrochloride Tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Yangtze River Pharmaceutical Group Co., Ltd.
Location
Peking, China
Timeline & enrollment
Phase
Phase 1
Start date
Dec 19, 2022
End date
Mar 21, 2023
Enrollment
22 participants
Primary outcome

Maximum change in systolic blood pressure (SBP),Maximum change in diastolic blood pressure (DBP),Maximum change in pulse,The area under effect-time curve (AUEC0- 4h) of supine SBP,The area under effect-time curve (AUEC0- 4h) of supine DBP,The area under effect-time curve (AUEC0- 4h) of pulse,Peak concentration (Cmax) of Tunodafil and metabolites M459,Area under drug time curve (AUC) of Tunodafil and metabolites M459,Peak concentration (Cmax) of alcohol

Summary

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.

ICD-10 classifications
Orgasmic dysfunctionOther disorders of penisOther specified disorders of penisSexual dysfunction, not caused by organic disorder or diseaseTesticular dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05976503
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05976503 through Pure Global AI's free database. This Phase 1 trial is sponsored by Yangtze River Pharmaceutical Group Co., Ltd. and is currently Completed. The study focuses on Erectile Dysfunction. Target enrollment is 22 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.