Hemodynamic and Pharmacokinetic Interactions of TPN171 with Alcohol in Healthy Male Subjects

被引：0

作者：

Cheng, Jie ^{[1
,2
,3
]}

Qian, Hongjie ^{[2
,4
]}

Wang, Yu ^{[5
]}

Liang, Liyu ^{[2
,4
]}

Xu, Wenjing ^{[2
,4
]}

Liu, Ye ^{[2
,4
]}

Chen, Qian ^{[2
,4
]}

Yu, Chen ^{[2
,4
]}

Duan, Huaqing ^{[6
]}

Wang, Zhen ^{[5
]}

Wang, Hang ^{[1
,3
]}

Jia, Jingying ^{[2
,4
]}

机构：

[1] Fudan Univ, Zhongshan Hosp, Dept Urol, Shanghai, Peoples R China

[2] Fudan Univ, Shanghai Xuhui Cent Hosp, Xuhui Hosp, Drug Clin Trial Ctr, Shanghai, Peoples R China

[3] Fudan Univ, Shanghai Xuhui Cent Hosp, Xuhui Hosp, Dept Urol, Shanghai, Peoples R China

[4] Shanghai Engn Res Ctr Phase I Clin Res & Qual Cons, Shanghai, Peoples R China

[5] Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai, Peoples R China

[6] Vigonvita Life Sci Co Ltd, Suzhou, Peoples R China

来源：

CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2025年 / 18卷 / 02期

关键词：

alcohol; healthy subjects; hemodynamics; PDE5; inhibitor; pharmacokinetics; TPN171; SILDENAFIL; INHIBITOR; MEN;

D O I：

10.1111/cts.70165

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

This study aimed to evaluate the effects of the concomitant administration of TPN171 and alcohol on hemodynamic and pharmacokinetic characteristics in healthy Chinese male subjects. Fifteen eligible subjects were randomly assigned to one of three sequences, each comprising three treatments: Treatment A (placebo +0.5 g/kg alcohol), Treatment B (TPN171 + 0.5 g/kg alcohol), and Treatment C (TPN171 + placebo). Enrolled subjects were administered with 10 mg TPN171 and/or 0.5 g/kg alcohol in fasting state in a randomized crossover design. Blood pressure, pulse rate (PR), blood samples, and breath alcohol test were measured at designated time points for hemodynamic and pharmacokinetic analyses. Compared with 10 mg TPN171 alone, administration of 10 mg TPN171 + 0.5 g/kg alcohol significantly lowered the area under the effect-time curve from 0 to 4 h (AUEC0-4h) of systolic blood pressure (95% confidence interval [CI]: -29.75 to -0.83, p = 0.039) and significantly increased AUEC0-4h of PR (95% CI: 7.47-28.92, p = 0.003). Compared with 0.5 g/kg alcohol alone, administration of 10 mg TPN171 + 0.5 g/kg alcohol contributed to significantly higher maximal increase of PR (95% CI: 2.78-9.44, p = 0.002) and AUEC0-4h of PR (95% CI: 1.08-24.52, p = 0.035). Alcohol had no influence on the pharmacokinetics of TPN171, and vice versa. Though the concomitant administration of TPN171 and alcohol induced a more pronounced increase in PR, this did not result in clinical symptoms or heart rate increase-related adverse events, indicating that the combined use was generally safe and well-tolerated.

引用

页数：8

共 18 条

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