Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers

Phase 1 Completed 58 enrolled Severance Hospital

NaSingle-groupOpen-labelTreatment

Summary

This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers

Timeline

Start: 2012-01
Primary completion: 2012-02
Completion: 2012-03

Publications

Son H, Roh H, Lee D, Chang H, Kim J, Yun C, Park K. Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. Clin Ther. 2013 Jul;35(7):915-22. doi: 10.1016/j.clinthera.2013.05.016. Epub 2013 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olmesartan	Other / unclassified	40 mg	Oral
Subject	Rosuvastatin	Small molecule	20 mg	Oral

Indications

No indication recorded.