Wuhan Changlian Laifu Pharmaceutical Co., Ltd.

Pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behaviors of the test preparation, ramelteon tablets provided by Wuhan Changlian Laifu Pharmaceutical Co., Ltd., and the reference preparation, ramelteon tablets (manufacturer: Takeda Pharmaceutical Company Limited, Japan, trade name: Rozerem®), in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.

This study studied the pharmacokinetic characteristics of a single oral self-prepared product taken on an empty stomach or after a meal, and used the levetiracetam sustained-release tablets produced by UCB as a reference preparation to compare the pharmacokinetic parameters, evaluate the bioavailability and human bioequivalence of the two preparations, and observe the tolerability and safety of levetiracetam sustained-release tablets in healthy people, so as to provide a reference for the registration application of the drug.

Pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behaviors of the test preparation, montelukast sodium chewable tablets provided by Wuhan Changlian Laifu Pharmaceutical Co., Ltd., and the reference preparation, montelukast sodium chewable tablets (manufacturer: Merck Sharp & Dohme Ltd., trade name: Singulair®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.