A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

Phase 1 Completed 61 enrolled Hanmi Pharmaceutical Company Limited

RandomizedCrossoverOpen-labelTreatment

Summary

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Timeline

Start: 2018-12-21
Primary completion: 2019-02-13
Completion: 2019-02-13

Publications

Park JW, Chung H, Kim JM, Kim NY, Hong SH, Kim KA, Park JY. Pharmacokinetics of a Fixed-Dose Combination Product of Amlodipine, Losartan, Ezetimibe, and Rosuvastatin and Its Comparison with Co-administration of Four Individual Components in Healthy Participants. Drugs R D. 2024 Jun;24(2):179-186. doi: 10.1007/s40268-024-00460-y. Epub 2024 May 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	—	—
Subject	Ezetimibe	Unknown	—	—
Subject	Losartan	Other / unclassified	—	—
Subject	Rosuvastatin	Small molecule	—	—

Indications

No indication recorded.