NCT01992601

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)	For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2013-11-25
• Last updated: 2013-11-25

Locations

1 site across 1 country: South Korea