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黄体酮注射液在中国健康绝经后女性中的生物等效性研究
[Translation] Bioequivalence study of progesterone injection in healthy Chinese postmenopausal women
主要目的:观察单次皮下注射受试制剂黄体酮注射液与参比制剂(商品名:Lubion)在中国健康绝经后女性体内的药代动力学特征,评估单次皮下注射黄体酮注射液两种制剂之间的生物等效性及个体内变异度。次要目的:观察受试制剂和参比制剂,在中国健康绝经后女性中的安全性。
[Translation] Main purpose: To observe the pharmacokinetic characteristics of a single subcutaneous injection of the test preparation progesterone injection and a reference preparation (trade name: Lubion) in healthy Chinese postmenopausal women, and to evaluate the two types of single subcutaneous injection of progesterone injection. Bioequivalence between formulations and intra-individual variability. Secondary objective: To observe the safety of the test preparation and reference preparation in healthy Chinese postmenopausal women.
黄体酮注射液在中国健康绝经后女性中的生物等效性研究
[Translation] Bioequivalence study of progesterone injection in Chinese healthy postmenopausal women
主要目的:观察单次皮下注射受试制剂黄体酮注射液与参比制剂(商品名:Lubion)在中国健康绝经后女性体内的药代动力学特征,评估单次皮下注射黄体酮注射液两种制剂之间的生物等效性及个体内变异度。次要目的:观察受试制剂和参比制剂,在中国健康绝经后女性中的安全性。
[Translation] The main purpose: To observe the pharmacokinetic characteristics of a single subcutaneous injection of the test preparation progesterone injection and the reference preparation (trade name: Lubion) in Chinese healthy postmenopausal women, and to evaluate the pharmacokinetic characteristics of the single subcutaneous injection of the two progesterone injections. Bioequivalence and intra-individual variability between preparations. Secondary objective: To observe the safety of the test preparation and the reference preparation in Chinese healthy postmenopausal women.
[Translation] Pharmacokinetic study of roflumilast tablets in humans
对罗氟司特片(受试制剂)进行健康人体三剂量单次及多次口服给药及食物影响药代动力学试验研究,探讨试验药物在人体内的吸收、分布和消除的药代动力学变化特点,为临床应用提供参考。
[Translation] Three-dose single and multiple oral administration of roflumilast tablets (the test preparation) in healthy humans and the effect of food on the pharmacokinetics were studied to explore the pharmacokinetics of the absorption, distribution and elimination of the test drug in the human body The characteristics of scientific changes can provide reference for clinical application.
100 Clinical Results associated with Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd.
0 Patents (Medical) associated with Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd.
100 Deals associated with Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd.
100 Translational Medicine associated with Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd.