{"title":"The Pharmacokinetics of Topical Finasteride 0.25% Spray in Chinese Adult Male Volunteers with Androgenic Alopecia: A Phase I Study.","authors":"Zongguang Tai, Zhen Cui, Xinwei Shi, Haiyan Li, Rongrong Chai, Yanping Huang, Yuanyuan Fang, Danyang Jia, Quangang Zhu, Zhongjian Chen","doi":"10.1007/s12325-025-03106-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>After single-dose administration, the C<sub>max</sub> of finasteride was 15.2 ± 5.54 pg/mL, T<sub>max</sub> was 11.00 (3.00, 20.00) h, AUC<sub>0-24h</sub> was 263 ± 76.6 h·pg/mL, t<sub>1/2</sub> was 35.3 ± 47.7 h, and CL/F was 974 ± 518 L/h. After 7 days of multiple doses, C<sub>max,ss</sub> was 29.7 ± 12.9 pg/mL, T<sub>max,ss</sub> was 8.00 (3.00, 12.00) h, AUC<sub>tau,ss</sub> was 530 ± 251 h·pg/mL, AUC<sub>0-t,ss</sub> was 790 ± 464 h·pg/mL, t<sub>1/2,ss</sub> was 22.6 ± 10.7 h, and CL/T<sub>ss</sub> was 1080 ± 658 L/h. No clinically significant adverse events occurred during the study.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s12325-025-03106-w","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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 Cmax of finasteride was 15.2 ± 5.54 pg/mL, Tmax was 11.00 (3.00, 20.00) h, AUC0-24h was 263 ± 76.6 h·pg/mL, t1/2 was 35.3 ± 47.7 h, and CL/F was 974 ± 518 L/h. After 7 days of multiple doses, Cmax,ss was 29.7 ± 12.9 pg/mL, Tmax,ss was 8.00 (3.00, 12.00) h, AUCtau,ss was 530 ± 251 h·pg/mL, AUC0-t,ss was 790 ± 464 h·pg/mL, t1/2,ss was 22.6 ± 10.7 h, and CL/Tss 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.
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.
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