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Introduction <p>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&#xa0;μL) after single and multiple doses in Chinese male volunteers with androgenetic alopecia.</p> Methods <p>Twelve male patients with androgenetic alopecia received once-daily scalp application of the solution for 7&#xa0;days. Blood samples were collected at specified time points (on day&#xa0;1, days&#xa0;3–6, and day&#xa0;7 of the trial) and plasma finasteride concentrations were determined by HPLC–MS.</p> Results <p>After single-dose administration, the <i>C</i><sub>max</sub> of finasteride was 15.2 ± 5.54&#xa0;pg/mL, <i>T</i><sub>max</sub> was 11.00 (3.00, 20.00)&#xa0;h, AUC<sub>0–24h</sub> was 263 ± 76.6&#xa0;h·pg/mL, <i>t</i><sub>1/2</sub> was 35.3 ± 47.7&#xa0;h, and CL/<i>F</i> was 974 ± 518&#xa0;L/h. After 7&#xa0;days of multiple doses, <i>C</i><sub>max,ss</sub> was 29.7 ± 12.9&#xa0;pg/mL, <i>T</i><sub>max,ss</sub> was 8.00 (3.00, 12.00)&#xa0;h, AUC<sub>tau,ss</sub> was 530 ± 251&#xa0;h·pg/mL, AUC<sub>0–<i>t</i>,ss</sub> was 790 ± 464&#xa0;h·pg/mL, <i>t</i><sub>1/2,ss</sub> was 22.6 ± 10.7&#xa0;h, and CL/<i>T</i><sub>ss</sub> was 1080 ± 658&#xa0;L/h. No clinically significant adverse events occurred during the study.</p> Conclusion <p>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&#xa0;days. Multiple-dose administration of finasteride spray was well tolerated in Chinese male volunteers with androgenetic alopecia.</p>

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

  • 期刊论文

  • 发表日期：

    2025年2月5日

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

摘要

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.