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

Boryung Pharmaceutical Co., Ltd100 enrolled

Overview

A Open-label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin versus 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

100

Conditions

Hypertension Hyperlipidemia

Interventions

Fimasartan/Amlodipine/RosuvastatinDRUG

Fimasartan/AmlodipineDRUG

RosuvastatinDRUG

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

Cmax of Fimasartan, Amlodipine and Rosuvastatin

Time frame: 0~144 hour after medication

AUCt(Area Under the Curve) of Fimasartan, Amlodipine and Rosuvastatin

Time frame: 0~144 hour after medication

Data from ClinicalTrials.gov

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