/ Not yet recruitingNot Applicable 黄体酮阴道缓释凝胶在健康受试者中空腹状态下的人体生物等效性试验
[Translation] Human bioequivalence study of progesterone sustained-release vaginal gel in healthy subjects under fasting condition
以台湾培力药品工业股份有限公司生产的黄体酮阴道缓释凝胶(规格:8%(90mg))为受试制剂,以Merck Serono Limited持证的黄体酮阴道缓释凝胶(商品名:雪诺同®,规格:8%(90mg))为参比制剂,研究受试制剂与参比制剂的吸收速度和吸收程度,评价两制剂在空腹条件下单次给药时的生物等效性。
[Translation] Methods: Progesterone vaginal sustained-release gel (specification: 8% (90 mg)) produced by Taiwan Pura-Pharma Co., Ltd. was used as the test preparation, and progesterone vaginal sustained-release gel (trade name: Serono®, specification: 8% (90 mg)) certified by Merck Serono Limited was used as the reference preparation. The absorption rate and extent of the test preparation and the reference preparation were studied, and the bioequivalence of the two preparations when administered once on an empty stomach was evaluated.
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