孟鲁司特钠咀嚼片在中国健康受试者中进行的人体生物等效性试验
[Translation] Human bioequivalence study of montelukast sodium chewable tablets in healthy Chinese subjects
1.观察中国健康受试者在空腹/餐后状态下单次口服受试制剂孟鲁司特钠咀嚼片和参比制剂孟鲁司特钠咀嚼片后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
2.观察受试制剂孟鲁司特钠咀嚼片和参比制剂孟鲁司特钠咀嚼片在中国健康受试者中的安全性。
[Translation] 1. To observe the pharmacokinetic characteristics of the test and reference montelukast sodium chewable tablets after a single oral administration in Chinese healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
2. To observe the safety of the test and reference montelukast sodium chewable tablets in Chinese healthy subjects.
普瑞巴林胶囊单中心、随机、开放、两周期、两交叉单次空腹及餐后状态下健康人体生物等效性试验
[Translation] A single-center, randomized, open-label, two-period, two-crossover bioequivalence study of pregabalin capsules in healthy volunteers in fasting and fed states
主要研究目的:考察空腹及餐后条件下受试制剂普瑞巴林胶囊与参比制剂普瑞巴林胶囊(商品名:乐瑞卡®)的单次口服的药动学特征,评价两制剂间的生物等效性。
次要研究目的:观察受试制剂普瑞巴林胶囊和参比制剂普瑞巴林胶囊(商品名:乐瑞卡®)在健康受试者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral dose of the test preparation Pregabalin Capsules and the reference preparation Pregabalin Capsules (trade name: Lyrica®) under fasting and postprandial conditions, and to evaluate the bioequivalence between the two preparations.
The secondary purpose of the study is to observe the safety of the test preparation Pregabalin Capsules and the reference preparation Pregabalin Capsules (trade name: Lyrica®) in healthy subjects.
来曲唑片在中国健康受试者中单次口服给药的一项单中心、随机、开放、双周期、双交叉生物等效性试验
[Translation] A single-center, randomized, open-label, two-period, double-crossover bioequivalence study of letrozole tablets administered orally as a single dose in healthy Chinese subjects
主要研究目的:考察空腹及餐后条件下受试制剂来曲唑片与参比制剂来曲唑片(商品名:弗隆)的单次口服的药动学特征,评价两制剂间的生物等效性。
次要研究目的:评价单次口服受试制剂来曲唑片或参比制剂(商品名:弗隆)在健康绝经后或人工绝育女性受试者中的安全性。
[Translation] The main purpose of the study is to investigate the pharmacokinetic characteristics of a single oral dose of the test preparation Letrozole Tablets and the reference preparation Letrozole Tablets (trade name: Fulong) under fasting and postprandial conditions, and to evaluate the bioequivalence between the two preparations.
Secondary purpose of the study is to evaluate the safety of a single oral dose of the test preparation Letrozole Tablets or the reference preparation (trade name: Fulong) in healthy postmenopausal or artificially sterilized female subjects.
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