NCT05316428

A Study of the Hemodynamic Interactions of TPN171H Tablets & Alcohol in Healthy Male Subjects

A Randomized, Blind, Placebo-controlled, Three-way Crossover Study Evaluating the Interaction of TPN171H Tablets and Alcohol in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.

Detailed description

This study will be divided into two parts: pre-test and formal test. The pre-trial is an open design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol, blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection were required, and the time point was the same as the formal test. The dosage of TPN171H tablets in the formal trial will be determined according to the preliminary test results. The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 3 days between treatments: Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet 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 one placebo tablet 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 one10 mg or 5 mg TPN171H tablet plus an oral dose of placebo drink mixed with fruit juice. For each treatment period, supine blood pressure and pulse rate will be measured pre-dose and every 15 minutes for 4 hours post-dose,and at 6h,8h,24h and 48h post-dose. Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel.

Conditions

• Alcohol
• Phosphodiesterase Inhibitor
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	TPN171H tablet plus alcohol	10 mg TPN171H tablet QD plus 0.5 g/kg alcohol
OTHER	alcohol	0.5 g/kg alcohol
DRUG	TPN171H tablet	10 mg TPN171H tablet QD

Timeline

• Start date: 2022-02-24
• Primary completion: 2022-04-02
• Completion: 2022-04-06
• First posted: 2022-04-07
• Last updated: 2022-05-23

Locations

1 site across 1 country: China