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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 苯磺酸美洛加巴林片在餐后条件下的人体生物等效性试验
[Translation] Bioequivalence study of melogabalin besylate tablets in humans under fed conditions
主要研究目的:本研究以杭州和康药业有限公司提供的苯磺酸美洛加巴林片【受试制剂T,规格:5mg(按C??H??NO?计)】为受试制剂,以DAIICHI SANKYO CO., LTD.持证的苯磺酸美洛加巴林片【参比制剂R,商品名:德力静®,规格:5mg(按C??H??NO?计)】为参比制剂,评价受试制剂和参比制剂在餐后条件下给药后的生物等效性。
次要研究目的:观察单次口服5mg(按C??H??NO?计)的苯磺酸美洛加巴林片受试制剂或参比制剂在健康受试者中的安全性。
[Translation] Main study purpose: This study used melogabalin besylate tablets [test preparation T, specification: 5 mg (calculated in C??H??NO?)] provided by Hangzhou Hekang Pharmaceutical Co., Ltd. as the test preparation, and melogabalin besylate tablets [reference preparation R, trade name: Delijing®, specification: 5 mg (calculated in C??H??NO?)] certified by DAIICHI SANKYO CO., LTD. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under postprandial conditions.
Secondary study purpose: To observe the safety of a single oral dose of 5 mg (calculated in C??H??NO?) of melogabalin besylate tablets test preparation or reference preparation in healthy subjects.
/ CompletedNot Applicable 苯磺酸美洛加巴林片在空腹条件下的人体生物等效性试验
[Translation] Bioequivalence study of melogabalin besylate tablets in humans under fasting conditions
主要研究目的:本研究以杭州和康药业有限公司提供的苯磺酸美洛加巴林片【受试制剂T,规格:5mg(按C??H??NO?计)】为受试制剂,以DAIICHI SANKYO CO., LTD.持证的苯磺酸美洛加巴林片【参比制剂R,商品名:德力静®,规格:5mg(按C??H??NO?计)】为参比制剂,评价受试制剂和参比制剂在空腹条件下给药后的生物等效性。
次要研究目的:观察单次口服5mg(按C??H??NO?计)的苯磺酸美洛加巴林片受试制剂或参比制剂在健康受试者中的安全性。
[Translation] Main study purpose: This study used melogabalin besylate tablets [test preparation T, specification: 5 mg (calculated in C??H??NO?)] provided by Hangzhou Hekang Pharmaceutical Co., Ltd. as the test preparation, and melogabalin besylate tablets [reference preparation R, trade name: Delijing®, specification: 5 mg (calculated in C??H??NO?)] certified by DAIICHI SANKYO CO., LTD. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting conditions.
Secondary study purpose: To observe the safety of a single oral dose of 5 mg (calculated in C??H??NO?) of melogabalin besylate tablets test preparation or reference preparation in healthy subjects.
/ 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.
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.