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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Subjects of Group 1 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 1 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 15th day.

Group Type OTHER

Fimasartan/Amlodipine/Rosuvastatin

Intervention Type DRUG

Fimasartan/Amlodipine

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Group 2

Subjects of Group 2 take a Fimasartan/Amlodipine/Rosuvastatin Combination Tablet at 1st day as period I. And then, after wash out for 2 weeks, as period II, subjects of Group 2 take Fimasartan/Amlodipine Combination Tablet and Rosuvastatin Individual Tablets at 15th day.

Group Type OTHER

Fimasartan/Amlodipine/Rosuvastatin

Intervention Type DRUG

Fimasartan/Amlodipine

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Interventions

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Fimasartan/Amlodipine/Rosuvastatin

Intervention Type DRUG

Fimasartan/Amlodipine

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes