Zhejiang Kangde Pharmaceutical Group Co. Ltd.

Using esomeprazole magnesium enteric-coated capsules (40 mg) provided by Zhejiang Kangde Pharmaceutical Group Co., Ltd. as the test formulation and esomeprazole magnesium enteric-coated capsules (trade name: NEXIUM®, 40 mg) certified by AstraZeneca Pharmaceuticals Lp as the reference formulation, the pharmacokinetic parameters and relative bioavailability of the two formulations under fasting, fasting, and postprandial administration were investigated to evaluate whether the two formulations were bioequivalent; and the safety of esomeprazole magnesium enteric-coated capsules in healthy trial participants was evaluated.

Bilasten orally disintegrating tablets (10 mg) manufactured by Zhejiang Kangde Pharmaceutical Group Co., Ltd. were used as the test formulation, and Bilasten orally disintegrating tablets (trade name: Bilaxten®, 10 mg) manufactured by FAES FARMA, S.A. were used as the reference formulation. The pharmacokinetic parameters and relative bioavailability of the two formulations under fasting conditions after a single dose were investigated to evaluate their bioequivalence. The safety of both formulations in healthy individuals was also evaluated.

The primary study objective was to investigate the pharmacokinetics of the test formulation, ezetimibe atorvastatin calcium tablets (strengths: 10 mg/20 mg, manufactured by Zhejiang Kangde Pharmaceutical Group Co., Ltd.), compared with the reference formulation, ezetimibe atorvastatin calcium tablets (Atozet®, strengths: 10 mg/20 mg, manufactured by Organon Heist bv), in healthy adult subjects after a single oral dose under fasting conditions, and to evaluate the bioequivalence of the two formulations when administered orally under fasting conditions. The secondary study objective was to evaluate the safety of the test formulation and the reference formulation in healthy subjects after a single oral dose under fasting conditions.