NCT01921946

To Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin

A Phase Ⅰ Study to Evaluate the Pharmacokinetic Interactions and Safety Between Fimasartan and Rosuvastatin in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A phase Ⅰ study to evaluate the pharmacokinetic interactions and safety between fimasartan and rosuvastatin in healthy male volunteers.

Detailed description

After subjects have signed informed consent voluntarily, they go through screening period for within 21 days. As period I, subjects of Part A take fimasartan for 7 days and subjects of Part B take rosuvastatin for 7 days. And then, after wash out for 7 days, as period II, subjects of both Part A and B take fimasartan and rosuvastatin for 7 days. At each period, subjects of Part A have blood sampling 2nd, 4th, 6th day before medication, 7th day before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48hour after medication(17 times in each period, 34 times in total). At each period, subjects of Part B have blood sampling 2nd, 4th, 6th day before medication, 7th day before and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, 12, 24, 48 and 72hour after medication(17 times in each period, 34 times in total).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan
DRUG	Rosuvastatin

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2013-08-14
• Last updated: 2013-10-22

Locations

1 site across 1 country: South Korea