Target- |
Mechanism- |
|
Originator Org.- |
|
Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date30 Dec 2019 |
|
Mechanism5-HT1A receptor agonists [+2] |
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Jul 2015 |
Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingPhase 1 SH081012口服用浓溶液在中国健康参与者中的药代动力学比较研究
[Translation] Comparative Pharmacokinetic Study of SH081012 Oral Concentrated Solution in Healthy Chinese Participants
主要目的:评价在健康参与者中空腹单次给予山东百诺医药股份有限公司提供的受试制剂SH081012口服用浓溶液500 mg(规格:3 mL:1 g)与特丰制药有限公司生产的参比制剂水合氯醛/糖浆组合包装500 mg[规格:水合氯醛浓缩液 1.342 g:1 g/糖浆(稀释液)9 mL]药代动力学(PK)特征的相似性,评价其相对生物利用度。
次要目的:评估山东百诺医药股份有限公司提供的受试制剂SH081012口服用浓溶液的安全性、药效动力学、口感、刺激性。
[Translation] Primary objective: To evaluate the pharmacokinetic (PK) similarity between a single fasting administration of the test formulation SH081012 oral concentrate 500 mg (3 mL: 1 g) provided by Shandong Bainuo Pharmaceutical Co., Ltd., and the reference formulation chloral hydrate/syrup combination package 500 mg [chloral hydrate concentrate 1.342 g: 1 g/syrup (diluent) 9 mL] manufactured by Tefeng Pharmaceutical Co., Ltd., and to assess their relative bioavailability.
Secondary objective: To evaluate the safety, pharmacodynamics, taste, and irritation of the test formulation SH081012 oral concentrate provided by Shandong Bainuo Pharmaceutical Co., Ltd.
/ CompletedNot Applicable [Translation] Human bioequivalence study of vardenafil hydrochloride orally disintegrating tablets
主要试验目的:研究空腹状态下单次口服受试制剂盐酸伐地那非口崩片(规格:10 mg;山东朗诺制药有限公司生产)与参比制剂盐酸伐地那非口崩片(规格:10 mg;Alembic Pharmaceuticals Limited生产)在健康成年男性试验参与者体内的药代动力学,评价空腹状态下口服两种制剂的生物等效性。
次要试验目的:评估受试制剂盐酸伐地那非口崩片(规格:10 mg)和参比制剂盐酸伐地那非口崩片(规格:10 mg)在健康男性试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation, vardenafil hydrochloride orally disintegrating tablets (10 mg; manufactured by Shandong Langnuo Pharmaceutical Co., Ltd.), and the reference formulation, vardenafil hydrochloride orally disintegrating tablets (10 mg; manufactured by Alembic Pharmaceuticals Limited), in healthy adult male participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions.
Secondary objective: To assess the safety of the test formulation, vardenafil hydrochloride orally disintegrating tablets (10 mg), and the reference formulation, vardenafil hydrochloride orally disintegrating tablets (10 mg), in healthy male participants.
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of atorvastatin calcium oral suspension
主要研究目的:研究空腹状态下单次口服受试制剂阿托伐他汀钙口服混悬液(规格:150 ml:0.6 g(按C33H35FN2O5计);生产商:山东朗诺制药有限公司)与参比制剂Atorvaliq®(规格:20 mg/5 ml;持证商:CMP DEVELOPMENT LLC)在健康成年试验参与者体内的药代动力学,评价空腹状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂阿托伐他汀钙口服混悬液(规格:150 ml:0.6 g(按C33H35FN2O5计)与参比制剂Atorvaliq®(规格:20 mg/5 ml)在健康成年试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation atorvastatin calcium oral suspension (150 ml: 0.6 g (C33H35FN2O5); manufacturer: Shandong Langnuo Pharmaceutical Co., Ltd.) and the reference formulation Atorvaliq® (20 mg/5 ml; licensee: CMP DEVELOPMENT LLC) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions.
Secondary objective: To evaluate the safety of the test formulation atorvastatin calcium oral suspension (150 ml: 0.6 g (C33H35FN2O5)) and the reference formulation Atorvaliq® (20 mg/5 ml) in healthy adult participants.
100 Clinical Results associated with Shandong Langnuo Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Shandong Langnuo Pharmaceutical Co. Ltd.
100 Deals associated with Shandong Langnuo Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Shandong Langnuo Pharmaceutical Co. Ltd.