NCT03753477

Clinical Trial to Investigate the Efficacy and Safety of DWJ1351

An Open-label, Randomized, 2X2 Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1351 and Co-administration of Amlodipine/Olmesartan and Rosuvastatin in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers

Detailed description

The purpose of this study is to compare the safety and pharmacokinetic characteristics of combination of amlodipine, olmesartan and rosuvastatin and DWJ1351 in healthy male volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)	DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)
DRUG	Sevikar and Crestor	Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)

Timeline

• Start date: 2017-12-22
• Primary completion: 2018-01-26
• Completion: 2018-02-01
• First posted: 2018-11-27
• Last updated: 2018-11-28

Locations

1 site across 1 country: South Korea