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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date27 May 1983 |
[Translation] Bioequivalence Study of Vardenafil Hydrochloride Orally Disintegrating Tablets in Human
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计评价海南美乐康药业有限公司提供的盐酸伐地那非口崩片(10 mg)与 Alembic Pharmaceuticals Inc.持证的盐酸伐地那非口崩片(10 mg)在健康男性人群空腹、餐后口服的生物等效性,为海南美乐康药业有限公司提供的盐酸伐地那非口崩片与 Alembic Pharmaceuticals Inc.持证的盐酸伐地那非口崩片临床疗效的一致性提供证据,并评价海南美乐康药业有限公司提供的盐酸伐地那非口崩片(10 mg)的安全性和耐受性。
[Translation] A single-center, randomized, open, double-period, self-crossover, single-dose administration design was used to evaluate vardenafil hydrochloride orally disintegrating tablets (10 mg) provided by Hainan Meilekang Pharmaceutical Co., Ltd. and Alembic Pharmaceuticals Inc. Bioequivalence of vardenafil hydrochloride orally disintegrating tablets (10 mg) in healthy male population on an empty stomach and after meals, vardenafil hydrochloride orally disintegrating tablets provided by Hainan Meilekang Pharmaceutical Co., Ltd. .Provide evidence for the consistency of clinical efficacy of vardenafil hydrochloride orally disintegrating tablets, and evaluate the safety and tolerability of vardenafil hydrochloride orally disintegrating tablets (10 mg) provided by Hainan Meilekang Pharmaceutical Co., Ltd. sex.
[Translation] Study on Bioequivalence of Ambroxol Hydrochloride Oral Spray Solution in Human
采用单中心、随机、开放、两周期、自身交叉、单剂量设计比较空腹和餐后给药条件下,海南美乐康药业有限公司提供的盐酸氨溴索口腔喷雾溶液(商品名:AMBROSPRAY ® 5%,规格:13 mL:650 mg(每喷含盐酸氨溴索10 mg))与OPELLA HEALTHCARE AUSTRIA GMBH持证的盐酸氨溴索口服溶液(商品名:Mucosolvan®,规格:15 mg/5 mL)在中国健康人群中的生物等效性,并评价海南美乐康药业有限公司提供的盐酸氨溴索口腔喷雾溶液的安全性。
[Translation] Using single-center, randomized, open, two-period, self-crossover, single-dose design to compare fasting and postprandial administration conditions, ambroxol hydrochloride oral spray solution (trade name: AMBROSPRAY ® ) provided by Hainan Meilekang Pharmaceutical Co., Ltd. 5%, specification: 13 mL: 650 mg (each spray contains 10 mg of ambroxol hydrochloride)) and ambroxol hydrochloride oral solution licensed by OPELLA HEALTHCARE AUSTRIA GMBH (trade name: Mucosolvan®, specification: 15 mg/5 mL ) in Chinese healthy population, and evaluate the safety of ambroxol hydrochloride oral spray solution provided by Hainan Meilekang Pharmaceutical Co., Ltd.
[Translation] Bioequivalence Study of Vardenafil Hydrochloride Orally Disintegrating Tablets in Human
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计评价海南美乐康药业有限公司提供的盐酸伐地那非口崩片(10 mg)与 Alembic Pharmaceuticals Inc.持证的盐酸伐地那非口崩片(10 mg)在健康男性人群空腹、餐后口服的生物等效性,为海南美乐康药业有限公司提供的盐酸伐地那非口崩片与 Alembic Pharmaceuticals Inc.持证的盐酸伐地那非口崩片临床疗效的一致性提供证据,并评价海南美乐康药业有限公司提供的盐酸伐地那非口崩片(10 mg)的安全性和耐受性。
[Translation] A single-center, randomized, open, double-period, self-crossover, single-dose administration design was used to evaluate vardenafil hydrochloride orally disintegrating tablets (10 mg) provided by Hainan Meilekang Pharmaceutical Co., Ltd. and Alembic Pharmaceuticals Inc. Bioequivalence of vardenafil hydrochloride orally disintegrating tablets (10 mg) in healthy male population on an empty stomach and after meals, vardenafil hydrochloride orally disintegrating tablets provided by Hainan Meilekang Pharmaceutical Co., Ltd. .Provide evidence for the consistency of clinical efficacy of vardenafil hydrochloride orally disintegrating tablets, and evaluate the safety and tolerability of vardenafil hydrochloride orally disintegrating tablets (10 mg) provided by Hainan Meilekang Pharmaceutical Co., Ltd. sex.
100 Clinical Results associated with Hainan Merlot Kang Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Hainan Merlot Kang Pharmaceutical Co., Ltd.
100 Deals associated with Hainan Merlot Kang Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Hainan Merlot Kang Pharmaceutical Co., Ltd.