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Mechanism5-HT3 receptor antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date10 Jul 1996 |
/ CompletedNot Applicable 布瑞哌唑口崩片在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of breprazol orodisintegrating tablets in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服由杭州和康药业有限公司提供的布瑞哌唑口崩片(受试制剂,规格:2mg)与相同条件下单次口服由大塚製薬株式会社持证的布瑞哌唑口崩片(参比制剂,商品名:Rexulti®OD Tablets,规格:2mg)的药动学特征,评价两制剂间的生物等效性及安全性。
[Translation] It was investigated whether healthy subjects took a single oral administration of Bripipiprazole orally disintegrating tablets (test preparation, specification: 2 mg) provided by Hangzhou Hekang Pharmaceutical Co., Ltd. under fasting and postprandial conditions and a single oral administration of the same drug under the same conditions. Pharmacokinetic characteristics of Brevipiprazole orally disintegrating tablets (reference preparation, trade name: Rexulti® OD Tablets, strength: 2 mg) certified by Otsuka Pharmaceutical Co., Ltd., and evaluation of bioequivalence and safety between the two preparations sex.
/ CompletedNot Applicable [Translation] Bioequivalence study of brepazole tablets in humans under fasting and fed conditions
本研究考察健康受试者在空腹及餐后条件下,单次口服由杭州和康药业有限公司提供的布瑞哌唑片(受试制剂,规格:2mg)与相同条件下单次口服由大塚製薬株式会社持证的布瑞哌唑片(参比制剂,商品名:Rexulti®,规格:2mg)的药动学特征,评价两制剂间的生物等效性及安全性。
[Translation] This study examined whether healthy subjects took a single oral administration of Bripipiprazole tablets (test preparation, specification: 2 mg) provided by Hangzhou Hekang Pharmaceutical Co., Ltd. under fasting and postprandial conditions, and a single oral administration of Bripipiprazole tablets provided by Hangzhou Hekang Pharmaceutical Co., Ltd. under the same conditions. Pharmacokinetic characteristics of Bripipiprazole tablets (reference preparation, trade name: Rexulti®, strength: 2 mg) licensed by Otsuka Manufacturing Co., Ltd. to evaluate the bioequivalence and safety between the two preparations.
/ CompletedNot Applicable 盐酸米诺环素胶囊在空腹及餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of minocycline hydrochloride capsules in humans under fasting and fed conditions
考察健康受试者在空腹及餐后条件下,单次口服1粒由杭州和康药业有限公司提供的盐酸米诺环素胶囊【受试制剂T,规格:100mg(按C23H27N3O7计)】与相同条件下单次口服1粒由Pfizer Japan Inc.持证的盐酸米诺环素胶囊【参比制剂R,商品名:MINOMYCIN®,规格:100mg(按C23H27N3O7计)】的药动学特征,评价两制剂的生物等效性及安全性。
[Translation] To investigate the pharmacokinetic characteristics of a single oral dose of minocycline hydrochloride capsule [test preparation T, strength: 100 mg (calculated as C23H27N3O7)] provided by Hangzhou Hekang Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions and a single oral dose of minocycline hydrochloride capsule [reference preparation R, trade name: MINOMYCIN®, strength: 100 mg (calculated as C23H27N3O7)] certified by Pfizer Japan Inc. under the same conditions, and to evaluate the bioequivalence and safety of the two preparations.
100 Clinical Results associated with Hangzhou Hekang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hangzhou Hekang Pharmaceutical Co., Ltd.
100 Deals associated with Hangzhou Hekang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hangzhou Hekang Pharmaceutical Co., Ltd.