Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment AB

S-\>S+C

Group Type EXPERIMENTAL

Sevikar(amlodipne/olmesartan)

Intervention Type DRUG

Treatment AB

crestor(Rosuvastatin)

Intervention Type DRUG

Treatment AB/Treatment C

Treatment C

C

Group Type EXPERIMENTAL

crestor(Rosuvastatin)

Intervention Type DRUG

Treatment AB/Treatment C

Interventions

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Sevikar(amlodipne/olmesartan)

Treatment AB

Intervention Type DRUG

crestor(Rosuvastatin)

Treatment AB/Treatment C

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects aged 19 - 55 years
* A body mass index in the range 19 - 27 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria

* Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker (\>140 g/week)
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes