Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-29 @ 10:55 PM
Study NCT ID:
NCT05976503
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2023-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol
Sponsor:
Yangtze River Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: