A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

Boryung Pharmaceutical Co., Ltd60 enrolled

Overview

An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension, Hyperlipidemia

Interventions

Fimasartan/Amlodipine combination drug, RosuvastatinDRUG

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Outcomes

Primary Outcomes

Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin

Time frame: 0~72 hour after medication

AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin

Time frame: 0~72 hour after medication

Data from ClinicalTrials.gov

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