Dr. Reddy’s (Beijing) Pharmaceutical Co. Ltd.

To evaluate the safety and efficacy of vigabatrin oral solution as a single drug for the treatment of infantile spasms in Chinese patients

Main purpose: This study used levothyroxine sodium tablets (specification: 50μg) produced by Dr. Reddy’s Laboratories Ltd. with STERIL-GENELIFESCIENCE SPVT.LTD as the test preparation, and levothyroxine sodium tablets (specification: 50μg, trade name: Euthyrox®) produced by Merck Sante S.A.S. with Merck KGaA, Darmstadt as the reference preparation according to the relevant provisions of bioequivalence studies, to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions. Secondary purpose: Observe the safety of the test preparation levothyroxine sodium tablets and the reference preparation levothyroxine sodium tablets (Euthyrox®) in healthy subjects.

Primary study objectives: To study the pharmacokinetics of a single oral dose of sacubitril-valsartan sodium tablets (24mg/26mg) (produced by Dr. Reddy’s Laboratories Limited, India) and a reference formulation (Entresto®, produced by Novartis Singapore Pharmaceutical Manufacturing Private. Ltd.) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two formulations in the fasting and fed state. Secondary study objectives: To study the safety of a single oral dose of sacubitril-valsartan sodium tablets (24mg/26mg) and a reference formulation in healthy adult subjects in the fasting and fed state.