NCT01823900

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

A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Severance Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test formulation	Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg
DRUG	Reference formulation	Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2013-04-04
• Last updated: 2013-04-11

Locations

1 site across 1 country: South Korea