[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence crossover bioequivalence study to evaluate the test preparation progesterone injection (specification: 1.112 ml: 25 mg) and the reference preparation Lubion® (specification: 1.112 ml: 25 mg) in healthy postmenopausal female subjects under fasting conditions
主要研究目的:研究空腹状态下单次注射受试制剂黄体酮注射液(规格:1.112 ml: 25 mg,持证商:河南科伦药业有限公司)与参比制剂黄体酮注射液(Lubion®,规格:1.112 ml: 25 mg,持证商:IBSA Farmaceutici Italia Srl)在健康绝经后女性受试者体内的药代动力学,评价空腹状态下注射两种制剂的生物等效性。
次要研究目的:评估受试制剂黄体酮注射液(规格:1.112 ml: 25 mg)和参比制剂黄体酮注射液(Lubion®,规格:1.112 ml: 25 mg)在健康绝经后女性受试者中的安全性。
[Translation] Primary study objective: To study the pharmacokinetics of a single injection of the test preparation progesterone injection (specification: 1.112 ml: 25 mg, licensee: Henan Kelun Pharmaceutical Co., Ltd.) and the reference preparation progesterone injection (Lubion®, specification: 1.112 ml: 25 mg, licensee: IBSA Farmaceutici Italia Srl) in healthy postmenopausal female subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations injected under fasting conditions.
Secondary study objective: To evaluate the safety of the test preparation progesterone injection (specification: 1.112 ml: 25 mg) and the reference preparation progesterone injection (Lubion®, specification: 1.112 ml: 25 mg) in healthy postmenopausal female subjects.