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

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

2016-10-31

Study Completion Date

2017-01-31

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

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Detailed Description

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This is an open-label, randomized, 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/Amlodipine and co-administration of Fimasartan and Amlodipine.

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 A

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

There will be a washout of 14 days between the each period.

Group Type EXPERIMENTAL

Fimasartan/Amlodipine

Intervention Type DRUG

Treatment B

Fimasartan + Amlodipine

Intervention Type DRUG

Treatment A

Sequence B

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

There will be a washout of 14 days between the each period.

Group Type EXPERIMENTAL

Fimasartan/Amlodipine

Intervention Type DRUG

Treatment B

Fimasartan + Amlodipine

Intervention Type DRUG

Treatment A

Sequency C

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

There will be a washout of 14 days between the each period.

Group Type EXPERIMENTAL

Fimasartan/Amlodipine

Intervention Type DRUG

Treatment B

Fimasartan + Amlodipine

Intervention Type DRUG

Treatment A

Interventions

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Fimasartan/Amlodipine

Treatment B

Intervention Type DRUG

Fimasartan + Amlodipine

Treatment A

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male 19-50 years of age.
2. Body mass index (BMI) ≥ 18 and ≤ 27 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 100/65 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within a month prior to the first dose of study drug.
5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes