A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Atorvastatin in Healthy Male 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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-23

Study Completion Date

2017-08-31

Brief Summary

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The purpose of this study is to evaluate the Pharmacokinetics and Safety / Tolerability of Fimasartan and Atorvastatin in Healthy Male volunteers.

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Detailed Description

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This is a randomized, open-label, single dose, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Atorvastatin and co-administration of Fimasartan and Atorvastatin.

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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A fixed dose combination group

A fixed dose combination of Fimasartan/Atorvastatin

Group Type EXPERIMENTAL

Fimasartan, Atorvastatin

Intervention Type DRUG

Co-administration group

Co-administration of Fimasartan and Atorvastatin

Group Type ACTIVE_COMPARATOR

Fimasartan, Atorvastatin

Intervention Type DRUG

Interventions

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Fimasartan, Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A Healthy male aged 19-50 years
* Body weight is over 55kg and BMI 18 \~ 27(kg/m2).
* A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
* A subject who is eligible according to investigator's assessment

Exclusion Criteria

* History or presence of clinically significant medical or psychiatric condition or disease.
* History of gastrointestinal disease and resection
* Hypersensitivity to ingredient of investigational product(IP) and other medication, food.
* Genetic Problem such as Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption.
* A subject who take a drug that inhibit or induce significantly Drug-Metabolizing Enzyme within 1months.
* Positive results for serum examination(HIV, B and C viral test, Syphilis).
* Seated BP is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
* Participation in any other study within 3months.
* History of whole blood donation within 2months and Apheresis 2 weeks.

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes