[Translation] A single-center, open, randomized, single-dose, four-period, two-sequence, completely repeated crossover bioequivalence study of oral administration of lipoic acid tablets in Chinese healthy subjects on an empty stomach
主要研究目的
研究空腹状态下单次口服受试制剂硫辛酸片(规格:0.6g,持证商:江苏和晨药业有限公司)与参比制剂硫辛酸片(Thioctacid®,规格:0.6g,持证商:MEDA Pharma GmbH & Co. KG/Viatris Healthcare GmbH),在健康成年受试者体内的药代动力学,评价空腹口服两种制剂的生物等效性。
次要研究目的
评价中国健康受试者空腹状态下,单次口服受试制剂硫辛酸片和参比制剂硫辛酸片(Thioctacid®)后的安全性。
[Translation] Main study objectives
To study the pharmacokinetics of a single oral dose of the test preparation lipoic acid tablets (specification: 0.6g, licensee: Jiangsu Hechen Pharmaceutical Co., Ltd.) and the reference preparation lipoic acid tablets (Thioctacid®, specification: 0.6g, licensee: MEDA Pharma GmbH & Co. KG/Viatris Healthcare GmbH) in healthy adult subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally on an empty stomach.
Secondary study objectives
To evaluate the safety of a single oral dose of the test preparation lipoic acid tablets and the reference preparation lipoic acid tablets (Thioctacid®) in healthy Chinese subjects under fasting conditions.