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A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol

NCT05976503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tunodafil Hydrochloride Tablets

100mg Tunodafil Hydrochloride Tablets

DRUG

Placebo

Placebo

OTHER

Alcohol

0.5 g/kg alcohol

Sponsors & Collaborators

  • Yangtze River Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-19
Primary Completion
2023-03-08
Completion
2023-03-21

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05976503 on ClinicalTrials.gov