|
|
|
|
|
Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 1 健康受试者口服替米沙坦氨氯地平片的 药代动力学及生物等效学研究
[Translation] Study on the pharmacokinetics and bioequivalence of oral telmisartan and amlodipine tablets in healthy volunteers
主要研究目的: 比较替米沙坦氨氯地平片40/5mg与原研替米沙坦氨氯地平片40/5mg药代动力学参数Cmax、 AUC0-t、 AUC0-inf之间的相似性,以及这些药代参数之间是否存在生物等效性。次要研究目的: 替米沙坦氨氯地平片的药代动力学研究; 比较替米沙坦氨氯地平片40/5mg与原研替米沙坦氨氯地平片40/5mg在健康人体的安全性。
[Translation] Primary study objectives: To compare the similarity of the pharmacokinetic parameters Cmax, AUC0-t, AUC0-inf between Telmisartan Amlodipine Tablets 40/5mg and original Telmisartan Amlodipine Tablets 40/5mg, and whether there is bioequivalence between these pharmacokinetic parameters. Secondary study objectives: Pharmacokinetic study of Telmisartan Amlodipine Tablets; To compare the safety of Telmisartan Amlodipine Tablets 40/5mg and original Telmisartan Amlodipine Tablets 40/5mg in healthy humans.
100 Clinical Results associated with Chengdu Zihao Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Chengdu Zihao Pharmaceutical Co., Ltd.
100 Deals associated with Chengdu Zihao Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Chengdu Zihao Pharmaceutical Co., Ltd.