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IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-02-05 DOI:10.1007/s12325-025-03106-w

Zongguang Tai, Zhen Cui, Xinwei Shi, Haiyan Li, Rongrong Chai, Yanping Huang, Yuanyuan Fang, Danyang Jia, Quangang Zhu, Zhongjian Chen

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引用次数: 0

摘要

研究简介本研究旨在评估中国雄激素性脱发男性志愿者使用非那雄胺局部喷雾剂（0.25% HPCH 溶液，每日一次，用量 200 μL）单次和多次用药后的药代动力学（PK）、安全性和局部耐受性：方法：12 名雄激素性脱发的男性患者每天一次在头皮上涂抹该溶液，连续 7 天。在规定的时间点（试验第1天、第3-6天和第7天）采集血样，用高效液相色谱-质谱法测定血浆中非那雄胺的浓度：单剂量给药后，非那雄胺的Cmax为15.2 ± 5.54 pg/mL，Tmax为11.00 (3.00, 20.00) h，AUC0-24h为263 ± 76.6 h-pg/mL，t1/2为35.3 ± 47.7 h，CL/F为974 ± 518 L/h。多次给药 7 天后，Cmax,ss 为 29.7 ± 12.9 pg/mL，Tmax,ss 为 8.00 (3.00, 12.00) h，AUCtau,ss 为 530 ± 251 h-pg/mL，AUC0-t,ss 为 790 ± 464 h-pg/mL，t1/2,ss 为 22.6 ± 10.7 h，CL/Tss 为 1080 ± 658 L/h。研究期间未发生临床重大不良反应：结论：与单剂量给药相比，非那雄胺多剂量给药的半衰期稳定，清除率变化极小，7天内暴露量约增加2倍。中国男性雄激素性脱发患者对非那雄胺喷雾剂多剂量给药的耐受性良好。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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The Pharmacokinetics of Topical Finasteride 0.25% Spray in Chinese Adult Male Volunteers with Androgenic Alopecia: A Phase I Study

Introduction

This study aimed to evaluate the pharmacokinetics (PK), safety, and local tolerability of local finasteride spray (0.25% solution in HPCH, once daily, volume 200 μL) after single and multiple doses in Chinese male volunteers with androgenetic alopecia.

Methods

Twelve male patients with androgenetic alopecia received once-daily scalp application of the solution for 7 days. Blood samples were collected at specified time points (on day 1, days 3–6, and day 7 of the trial) and plasma finasteride concentrations were determined by HPLC–MS.

Results

After single-dose administration, the C_max of finasteride was 15.2 ± 5.54 pg/mL, T_max was 11.00 (3.00, 20.00) h, AUC_0–24h was 263 ± 76.6 h·pg/mL, t_1/2 was 35.3 ± 47.7 h, and CL/F was 974 ± 518 L/h. After 7 days of multiple doses, C_max,ss was 29.7 ± 12.9 pg/mL, T_max,ss was 8.00 (3.00, 12.00) h, AUC_tau,ss was 530 ± 251 h·pg/mL, AUC_0–t,ss was 790 ± 464 h·pg/mL, t_1/2,ss was 22.6 ± 10.7 h, and CL/T_ss was 1080 ± 658 L/h. No clinically significant adverse events occurred during the study.

Conclusion

Compared to single-dose administration, multiple-dose administration of finasteride resulted in a stable half-life, minimal changes in clearance rate, and approximately twofold accumulation in exposure over 7 days. Multiple-dose administration of finasteride spray was well tolerated in Chinese male volunteers with androgenetic alopecia.

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.