NCT01918358

Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg

A Randomized, Open-label, Single Dose Crossover Study to Compare the Safety and Pharmacokinetics Between Fixed-dose Combination VR 160/20 mg and Co-administration of Diovan® (Valsartan) Film-coated Tablet 160 mg and Crestor® (Rosuvastatin) 20 mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the safety and pharmacokinetics between ROVATITAN tab. 160/20 mg (ROVATITAN tab 160/20mg-1, ROVATITAN tab. 160/20mg-2) and coadministration of Diovan® (Valsartan) 160 mg and Crestor® (Rosuvastatin) 20 mg in healthy male volunteers

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)
DRUG	Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1)
DRUG	Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)
DRUG	Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 )
DRUG	Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )
DRUG	Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2013-08-07
• Last updated: 2013-08-07

Locations

1 site across 1 country: South Korea