Clinical Re-evaluation on Bioequivalence and Relative Bioavailability of Micronized Progesterone Hard Capsule (Yimaxin) and Micronized Progesterone Soft Capsule (Utrogestan) under Vaginal and Oral Administration Routes

  • Hanbi Wang Peking Union Medical College Hospital
  • Meizhi Liu
  • Rui Chen
  • Chenyan Deng
Keywords: Micronized progesterone hard capsule, Micronized progesterone soft capsule, Bioequivalence, Bioavailability, pharmacokinetics

Abstract

Background and Objective: To clinically re-evaluate relative bioavailability and bioequivalence of micronized progesterone (hard capsule) Yimaxin and micronized progesterone (soft capsule) Utrogestan under vaginal and oral administration routes.

Methods: From December 2017 to June 2018, a total of 16 postmenopausal healthy women were recruited and received a total of four rounds of drug treatment with cross-over design, respectively Yimaxin and Utrogestan under vaginal and oral administration routes. Changes in the subjects’ hormone levels after medication were monitored and an endometrial biopsy after a course of treatment was performed in our hospital.

Result: The Geomeans of AUC0-t of Yimaxin and Utrogestan under vaginal administration route were 252.15 and 115.46, respectively, with a ratio of 2.19, and under oral administration route were 244.64 and 413.68, respectively, with a ratio of 0.59. The Geomeans of Cmax of Yimaxin and Utrogestan under vaginal administration route were 28.11 and 12.21, respectively, with a ratio of 2.30, and under oral administration route were 53.12 and 129.85, respectively, with a ratio of 0.41.

Conclusion: Yimaxin was not bioequivalent to Utrogestan. Yimaxin had higher exposure to the drug in vivo at the same dose when administered vaginally, and Utrogestan had higher exposure to the drug in vivo at the same dose when administered orally.

doi: https://doi.org/10.12669/pjms.37.7.3949

How to cite this:
Wang H, Liu M, Chen R, Deng C. Clinical Re-evaluation on Bioequivalence and Relative Bioavailability of Micronized Progesterone Hard Capsule (Yimaxin) and Micronized Progesterone Soft Capsule (Utrogestan) under Vaginal and Oral Administration Routes. Pak J Med Sci. 2021;37(7):1740-1746. doi: https://doi.org/10.12669/pjms.37.7.3949

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Published
2021-10-05
How to Cite
Wang, H., Liu, M., Chen, R., & Deng, C. (2021). Clinical Re-evaluation on Bioequivalence and Relative Bioavailability of Micronized Progesterone Hard Capsule (Yimaxin) and Micronized Progesterone Soft Capsule (Utrogestan) under Vaginal and Oral Administration Routes. Pakistan Journal of Medical Sciences, 37(7). https://doi.org/10.12669/pjms.37.7.3949
Section
Original Articles