A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

Phase 1

Completed

• Conditions: Hyperlipidemia; Hypertension
• Interventions: Drug: Fimasartan/Atorvastatin Combination Tablet; Drug: Fimasartan; Drug: Atorvastatin

• Registration Number: NCT02566187
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-30
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99

Inclusion Criteria

• a Healthy male subject, aged 19- 50 years

Exclusion Criteria

• History of clinically significant hypersensitivity to study drug, any other drug
• Hypotension or hypertension
• Active liver disease
• History of gastrointestinal disease
• History of excessive alcohol abuse
• Participation in any other study within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Fimasartan/Atorvastatin Combination Tablet	Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.
Group 1	Fimasartan/Atorvastatin Combination Tablet	Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.
Group 1	Fimasartan	Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.
Group 1	Atorvastatin	Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.
Group 2	Fimasartan	Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.
Group 2	Atorvastatin	Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin	0~48 hour after medication
Area under the curve(AUCt) of Fimasartan and Atorvastatin	0~48 hour after medication

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of