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

Boryung Pharmaceutical Co., Ltd99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Hyperlipidemia

Interventions

Fimasartan/Atorvastatin Combination TabletDRUG

FimasartanDRUG

AtorvastatinDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Inje University Busan Paik Hospital

Busan, South Korea

Outcomes

Primary Outcomes

Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin

Time frame: 0~48 hour after medication

Area under the curve(AUCt) of Fimasartan and Atorvastatin

Time frame: 0~48 hour after medication

Data from ClinicalTrials.gov

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