Hemodynamic and Pharmacokinetic Interactions of TPN171 with Alcohol in Healthy Male Subjects
文献类型：期刊论文
| 作者 | Cheng, Jie4,5,6; Qian, Hongjie3,5; Wang, Yu2; Liang, Liyu3,5; Xu, Wenjing3,5; Liu, Ye3,5; Chen, Qian3,5; Yu, Chen3,5; Duan, Huaqing1; Wang, Zhen2
|
| 刊名 | CTS-CLINICAL AND TRANSLATIONAL SCIENCE
 |
| 出版日期 | 2025-02-01 |
| 卷号 | 18期号:2页码:8 |
| 关键词 | alcohol healthy subjects hemodynamics PDE5 inhibitor pharmacokinetics TPN171 |
| ISSN号 | 1752-8054 |
| DOI | 10.1111/cts.70165 |
| 英文摘要 | 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. |
| WOS关键词 | SILDENAFIL ; INHIBITOR ; MEN |
| 资助项目 | Vigonvita Life Sciences Co. Ltd. ; Science and Technology Commission of Shanghai Municipality[18DZ2250500] ; Science and Technology Commission of Shanghai Municipality[23DZ2291800] ; Scientific Research Program of Shanghai Municipal Health Commission[20214Y0475] |
| WOS研究方向 | Research & Experimental Medicine |
| 语种 | 英语 |
| WOS记录号 | WOS:001422811800001 |
| 出版者 | WILEY |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/316284]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Duan, Huaqing; Wang, Zhen; Wang, Hang; Jia, Jingying |
| 作者单位 | 1.Vigonvita Life Sci Co Ltd, Suzhou, Peoples R China 2.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai, Peoples R China 3.Shanghai Engn Res Ctr Phase I Clin Res & Qual Cons, Shanghai, Peoples R China 4.Fudan Univ, Shanghai Xuhui Cent Hosp, Xuhui Hosp, Dept Urol, Shanghai, Peoples R China 5.Fudan Univ, Shanghai Xuhui Cent Hosp, Xuhui Hosp, Drug Clin Trial Ctr, Shanghai, Peoples R China 6.Fudan Univ, Zhongshan Hosp, Dept Urol, Shanghai, Peoples R China |
| 推荐引用方式 GB/T 7714 | Cheng, Jie,Qian, Hongjie,Wang, Yu,et al. Hemodynamic and Pharmacokinetic Interactions of TPN171 with Alcohol in Healthy Male Subjects[J]. CTS-CLINICAL AND TRANSLATIONAL SCIENCE,2025,18(2):8. |
| APA | Cheng, Jie.,Qian, Hongjie.,Wang, Yu.,Liang, Liyu.,Xu, Wenjing.,...&Jia, Jingying.(2025).Hemodynamic and Pharmacokinetic Interactions of TPN171 with Alcohol in Healthy Male Subjects.CTS-CLINICAL AND TRANSLATIONAL SCIENCE,18(2),8. |
| MLA | Cheng, Jie,et al."Hemodynamic and Pharmacokinetic Interactions of TPN171 with Alcohol in Healthy Male Subjects".CTS-CLINICAL AND TRANSLATIONAL SCIENCE 18.2(2025):8. |
入库方式： OAI收割
来源：上海药物研究所
浏览0
下载0
收藏0
其他版本
除非特别说明，本系统中所有内容都受版权保护，并保留所有权利。