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MechanismmAChRs antagonists |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.JP |
First Approval Date20 Jul 1968 |
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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
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Inactive Indication- |
Drug Highest PhaseIND Approval |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Bioequivalence test of sildenafil citrate tablets
主要目的:健康受试者在空腹或餐后状态下,以辉瑞制药有限公司持有的枸橼酸西地那非片(商品名:万艾可®;规格:100mg)为参比制剂,研究乐普药业股份有限公司研制的枸橼酸西地那非片(规格:100mg)的吸收速度与吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] Main purpose: To study Lepu in healthy subjects under fasting or postprandial conditions, using Sildenafil Citrate Tablets (trade name: Viagra®; Specification: 100mg) held by Pfizer Pharmaceuticals Co., Ltd. as a reference preparation. The absorption speed and extent of sildenafil citrate tablets (specification: 100mg) developed by Pharmaceutical Co., Ltd. were evaluated to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose: To observe the safety of oral administration of the test preparation and reference preparation to healthy subjects.
[Translation] Bioequivalence Test of Empagliflozin and Metformin Sustained Release Tablets
主要目的:在健康受试者体内,在空腹和餐后条件下,以Boehringer Ingelheim Pharmaceuticals, Inc持有的恩格列净二甲双胍缓释片(商品名:SYNJARDY® XR;规格:恩格列净5 mg /盐酸二甲双胍1000 mg)为参比制剂,研究乐普药业股份有限公司研制的恩格列净二甲双胍缓释片(规格:恩格列净5 mg /盐酸二甲双胍1000 mg)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] Main purpose: In healthy subjects, under fasting and postprandial conditions, Boehringer Ingelheim Pharmaceuticals, Inc held Empagliflozin Metformin Sustained Release Tablets (trade name: SYNJARDY® XR; specification: Empagliflozin 5 mg/metformin hydrochloride 1000 mg) was used as the reference preparation to study the pharmacokinetics of empagliflozin metformin sustained-release tablets (specification: empagliflozin 5 mg/metformin hydrochloride 1000 mg) developed by Lepu Pharmaceutical Co., Ltd. , to evaluate whether the test preparation is bioequivalent to the reference preparation.
Secondary purpose: To observe the safety of oral test preparation and reference preparation in healthy subjects.
[Translation] Bioequivalence Test of Sacubitril and Valsartan Sodium Tablets
主要目的:健康受试者在空腹和餐后条件下,以Novartis Pharma Schweiz AG持有的沙库巴曲缬沙坦钠片(商品名:诺欣妥®;规格:100 mg,沙库巴曲49 mg/缬沙坦51 mg)为参比制剂,研究乐普药业股份有限公司研制的沙库巴曲缬沙坦钠片(规格:100 mg,沙库巴曲49 mg/缬沙坦51 mg)的药代动力学,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察健康受试者口服受试制剂、参比制剂的安全性。
[Translation] Main purpose: Under fasting and postprandial conditions, healthy subjects were treated with sacubitril valsartan sodium tablets held by Novartis Pharma Schweiz AG (trade name: Nuoxintuo®; specification: 100 mg, sacubitril 49 mg/valsartan 51 mg) was used as the reference preparation, and sacubitril valsartan sodium tablets (specification: 100 mg, sacubitril 49 mg/valsartan 51 mg) developed by Lepu Pharmaceutical Co., Ltd. mg) pharmacokinetics to evaluate the bioequivalence between the test preparation and the reference preparation.
Secondary purpose: To observe the safety of oral test preparation and reference preparation in healthy subjects.
100 Clinical Results associated with Beijing Lepu Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Beijing Lepu Pharmaceutical Technology Co., Ltd.
100 Deals associated with Beijing Lepu Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Beijing Lepu Pharmaceutical Technology Co., Ltd.