NCT01918709

Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers

A Randomized, Open Label, Multiple Dose, Cross-over, Phase I Trial to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Primary objective : To investigate pharmacokinetics after concomitant administration of valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in healthy male volunteers Secondary objective : To investigate safety profiles after the administration of valsartan or rosuvastatin alone and concomitant administration of valsartan and rosuvastatin in healthy male volunteers

Conditions

• Hypertension, Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)	Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
DRUG	Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)	Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
DRUG	Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)	Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
DRUG	Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)	Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
DRUG	Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)	Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
DRUG	Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)	Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2013-08-08
• Last updated: 2013-08-08

Locations

1 site across 1 country: South Korea