A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer

Summary

This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration. Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration. The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period. The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.

Timeline

Start

2012-11

Primary completion

2012-12

Completion

2013-01

Publications

• Son M, Kim Y, Lee D, Roh H, Son H, Guk J, Jang SB, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and telmisartan in healthy Korean male volunteers: a randomized, open-label, two-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1147-58. doi: 10.1016/j.clinthera.2014.06.007. Epub 2014 Jul 3.

Drugs

Indications

No indication recorded.