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A Study to Compare the Pharma...

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

Last Updated: 2017-08-10

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-26

Study Completion Date

2017-05-30

Brief Summary

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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.

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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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1

A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin

Group Type EXPERIMENTAL

Fimasartan/Amlodipine combination drug, Rosuvastatin

Intervention Type DRUG

2

Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin

Group Type ACTIVE_COMPARATOR

Fimasartan/Amlodipine combination drug, Rosuvastatin

Intervention Type DRUG

Interventions

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Fimasartan/Amlodipine combination drug, Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes