/ CompletedNot Applicable 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.
/ CompletedNot Applicable 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.
/ CompletedNot Applicable 伏立康唑片在中国健康志愿者中进行的人体生物等效性试验
[Translation] Human bioequivalence study of voriconazole tablets in Chinese healthy volunteers
主要目的:观察中国健康志愿者在空腹状态下单次口服受试制剂伏立康唑片和参比制剂伏立康唑片(商品名:VFEND ®)后的药代动力学特征,评价空腹状态下两种制剂的生物等效性。 次要目的:观察受试制剂伏立康唑片和参比制剂伏立康唑片在中国健康志愿者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation voriconazole tablets and the reference preparation voriconazole tablets (trade name: VFEND ®) after a single oral administration in Chinese healthy volunteers in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state. Secondary objective: To observe the safety of the test preparation voriconazole tablets and the reference preparation voriconazole tablets in Chinese healthy volunteers.
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