A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

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Detailed Description

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This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequence 1 (ABC)

Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)

There will be a washout of at least 7 days between the each period.

Group Type OTHER

Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Sequence 2 (ACB)

Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)

There will be a washout of at least 7 days between the each period.

Group Type OTHER

Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Sequence 3 (BAC)

Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)

There will be a washout of at least 7 days between the each period.

Group Type OTHER

Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Sequence 4 (BCA)

Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)

There will be a washout of at least 7 days between the each period.

Group Type OTHER

Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Sequence 5 (CAB)

Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)

There will be a washout of at least 7 days between the each period.

Group Type OTHER

Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Sequence 6 (CBA)

Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)

There will be a washout of at least 7 days between the each period.

Group Type OTHER

Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Interventions

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Fimasartan

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Fimasartan + Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Caucasian male 19-55 years of age.
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within 7 days prior to the first dose of study drug.
5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes