NCT02205190

to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin

A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/rosuvastatin combination tablet and coadministration of 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 1 Group take fimasartan and rosuvastatin at 1st day and subjects of 2 Group take fimasartan/rosuvastatin combination at 1st day. And then, after wash out for 7 days, as period II, subjects of 1 Group take fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and rosuvastatin at 8th day. At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total). At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in total).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Fimasartan
DRUG	Rosuvastatin
DRUG	Fimasartan/Rosuvastatin combination

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-07-31
• Last updated: 2014-10-15

Locations

1 site across 1 country: South Korea