Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers

Phase 1 Completed 50 enrolled Severance Hospital

NaSingle-groupOpen-labelTreatment

Summary

This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers

Timeline

Start: 2012-07
Primary completion: 2012-08
Completion: 2012-09

Publications

Kim Y, Son M, Lee D, Roh H, Son H, Chae D, Bahng MY, Park K. Pharmacokinetic comparison of 2 fixed-dose combination tablets of amlodipine and valsartan in healthy male Korean volunteers: a randomized, open-label, 2-period, single-dose, crossover study. Clin Ther. 2013 Jul;35(7):934-40. doi: 10.1016/j.clinthera.2013.05.021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	10 mg	Oral
Subject	Valsartan	Small molecule	160 mg	Oral

Indications

No indication recorded.