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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 study 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] Primary purpose: To study the absorption rate and extent of sildenafil citrate tablets (specification: 100 mg) developed by Lepu Pharmaceutical Co., Ltd., using sildenafil citrate tablets (trade name: Viagra®; specification: 100 mg) held by Pfizer Pharmaceuticals Co., Ltd. as the reference preparation in healthy subjects under fasting or postprandial conditions, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary purpose: To observe the safety of oral test preparations and reference preparations in healthy subjects.
[Translation] Bioequivalence study of empagliflozin and metformin extended-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] Primary objective: To study the pharmacokinetics of empagliflozin metformin extended-release tablets (specifications: empagliflozin 5 mg/metformin hydrochloride 1000 mg) developed by Lepu Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects, using empagliflozin metformin extended-release tablets (trade name: SYNJARDY® XR; specifications: empagliflozin 5 mg/metformin hydrochloride 1000 mg) held by Boehringer Ingelheim Pharmaceuticals, Inc as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of the test preparation and the reference preparation in oral administration to healthy subjects.
[Translation] Bioequivalence study of ritonavir tablets
主要目的:在健康受试者体内,空腹和餐后状态下,以利托那韦片(规格:100mg,商品名:NORVIR)为参比制剂,研究乐普制药科技有限公司研制的利托那韦片(规格:100mg;受试制剂)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] Primary objective: To study the pharmacokinetics of ritonavir tablets (specification: 100 mg; test preparation) developed by Lepu Pharmaceutical Technology Co., Ltd. in healthy subjects in fasting and postprandial states, using ritonavir tablets (specification: 100 mg, trade name: NORVIR) as the reference preparation, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: 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.