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A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol - Trial NCT05976503

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.

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NCT05976503
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05976503
View on ClinicalTrials.gov
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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

Study Focus

Erectile Dysfunction

Tunodafil Hydrochloride Tablets

Interventional

drug

Sponsor & Location

Yangtze River Pharmaceutical Group Co., Ltd.

Peking, China

Timeline & Enrollment

Phase 1

Dec 19, 2022

Mar 21, 2023

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 dysfunction
Other disorders of penis
Other specified disorders of penis
Sexual dysfunction, not caused by organic disorder or disease
Testicular dysfunction

Data Source

ClinicalTrials.gov

NCT05976503

Non-Device Trial