Hunan Dongting Pharmaceutical Co., Ltd.

To investigate the pharmacokinetic characteristics of healthy study participants after a single oral administration of clonazepam tablets (test preparation, strength: 2 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd. and a single oral administration of clonazepam tablets (reference preparation, trade name: Klonopin®, strength: 2 mg) certified by CHEPLAPHARM Arzneimittel GmbH under the same conditions, under fasting and postprandial conditions. The bioequivalence and safety of the two preparations were evaluated, providing a basis for the consistency evaluation of the test preparation.

This study aimed to investigate the pharmacokinetic characteristics of estazolam tablets (2 mg) developed and produced by Hunan Dongting Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Using estazolam tablets (EURODIN®, 2 mg) licensed by Teva Takeda Yakuhin Ltd. and manufactured by Takeda Teba Pharmaceutical Co., Ltd. as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate their bioequivalence in humans.

This study examined the oral administration of a single dose of alprazolam tablets (test preparation, specification: 0.4 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd. or Alprazolam tablets produced by Biotech Co., Ltd. to healthy subjects under fasting and postprandial conditions. (Viatoris Pharmaceutical Co., Ltd.) Pharmacokinetic characteristics of certified alprazolam tablets (reference preparation, trade name: Solanax®, strength: 0.4 mg), to evaluate the bioequivalence and safety of the two preparations, which subject Provide a basis for consistency evaluation of trial preparations.