NCT01609907

Pharmacokinetic Drug Interaction Between Rosuvastatin and Valsartan

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare pharmacokinetics after single oral administration of rosuvastatin and valsartan each separately versus coadministration of rosuvastatin and valsartan in healthy male volunteers.

Conditions

• Hypertension
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Rosuvastatin+Valsartan (Sequence 1)	Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
DRUG	Rosuvastatin+Valsartan (Sequence 2)	Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
DRUG	Rosuvastatin+Valsartan (Sequence 3)	Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
DRUG	Rosuvastatin+Valsartan (Sequence 4)	Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
DRUG	Rosuvastatin+Valsartan (Sequence 5)	Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
DRUG	Rosuvastatin+Valsartan (Sequence 6)	Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-06-01
• Last updated: 2012-06-01

Locations

1 site across 1 country: South Korea