[Translation] A randomized, open-label, single-dose, two-formulation, two-cycle, two-sequence, self-crossover bioequivalence study of biotin tablets in healthy participants in China, under fasting and postprandial conditions.
以北京斯利安药业有限公司生产的生物素片(规格:10mg)为受试制剂,Strathmann GmbH & Co. KG生产、北京斯利安药业有限公司提供的生物素片(规格:10mg,商品名:Gabunat®)为参比制剂,在空腹和餐后状态下评价受试制剂和参比制剂在健康试验参与者中的生物等效性。
次要目的:观察空腹和餐后状态下受试制剂和参比制剂在健康试验参与者中的安全性。
[Translation] This study evaluated the bioequivalence of the test and reference formulations in healthy participants under fasting and postprandial conditions using biotin tablets (10 mg, manufactured by Beijing Silian Pharmaceutical Co., Ltd.) as the test formulation and biotin tablets (10 mg, trade name: Gabunat®, manufactured by Strathmann GmbH & Co. KG and supplied by Beijing Silian Pharmaceutical Co., Ltd.) as the reference formulation.
Secondary objective: To observe the safety of the test and reference formulations in healthy participants under fasting and postprandial conditions.