Pharmacokinetics, pharmacodynamics, and safety interaction study of tunodafil hydrochloride and alcohol: A randomized, blinded, placebo-controlled, three-cycle crossover study in Chinese healthy men
Abstract
Objectives: This study aimed to evaluate the pharmacodynamic effects of administering tunodafil hydrochloride with alcohol on blood pressure and heart rate in healthy Chinese males, and to investigate the mutual pharmacokinetic interactions and safety of the combination.
Methods: The trial was a randomized, blinded, placebo-controlled, three-cycle crossover design, with one administration in each cycle and a 7-day washout interval between cycles. Eighteen healthy men were randomized to receive tunodafil hydrochloride with an alcoholic beverage, placebo with an alcoholic beverage, or tunodafil hydrochloride with a placebo beverage in each cycle. The primary endpoints included plasma concentrations of tunodafil, metabolite M459, and alcohol, as well as supine blood pressure and heart rate measurements. The secondary endpoint was the incidence of adverse events.
Results: Pharmacokinetic results demonstrated that the combined drug and alcohol group did not affect plasma alcohol concentration compared to alcohol alone. However, co-administration led to increased systemic exposure of tunodafil and its metabolite M459: AUC0-∞ rose by 42.89% and 28.75%, while Cmax increased by 74.46% and 39.32%, respectively, compared to the drug alone group. Pharmacodynamic analysis indicated that the reduction in blood pressure was primarily driven by alcohol consumption, with no significant additional effect from tunodafil co-administration. In contrast, heart rate elevation was notably amplified…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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