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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Peking University People's Hospital
Beijing, China
Maximum change in systolic blood pressure (SBP)
Maximum change from baseline in decubitus (semi-decubitus) SBP.
Time frame: 4 hours after treatment
Maximum change in diastolic blood pressure (DBP)
Maximum change from baseline in decubitus (semi-decubitus) DBP.
Time frame: 4 hours after treatment
Maximum change in pulse
Maximum change from baseline in decubitus (semi-decubitus) position.
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine SBP
The area under effect-time curve (AUEC0- 4h) of supine SBP relative to baseline change.
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine DBP
The area under effect-time curve (AUEC0- 4h) of supine DBP relative to baseline change.
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of pulse
The area under effect-time curve (AUEC0- 4h) of pulse relative to baseline change.
Time frame: 4 hours after treatment
Peak concentration (Cmax) of Tunodafil and metabolites M459
Time frame: 24 hours after treatment
Area under drug time curve (AUC) of Tunodafil and metabolites M459
Time frame: 24 hours after treatment
Peak concentration (Cmax) of alcohol
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Time frame: 8 hours after treatment
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
A treatment-emergent adverse events (TEAE) is defined as any unfavorable and unintended sign,symptom or disease temporally associated with the use of a study drug.
Time frame: 7 days after treatment