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

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-18

Study Completion Date

2019-06-30

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.

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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/Linagliptin and co-administration of Fimasartan and Linagliptin.

Conditions

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Hypertension Diabetes

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 35 days between the each period.

Group Type EXPERIMENTAL

Treatment A (Fimasartan, Linagliptin)

Intervention Type DRUG

Co-administration of Fimasartan and Linagliptin

Treatment B (Fimasartan/Linagliptin)

Intervention Type DRUG

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Sequence B

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

There will be a washout of 35 days between the each period.

Group Type EXPERIMENTAL

Treatment A (Fimasartan, Linagliptin)

Intervention Type DRUG

Co-administration of Fimasartan and Linagliptin

Treatment B (Fimasartan/Linagliptin)

Intervention Type DRUG

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Sequency C

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

There will be a washout of 35 days between the each period.

Group Type EXPERIMENTAL

Treatment A (Fimasartan, Linagliptin)

Intervention Type DRUG

Co-administration of Fimasartan and Linagliptin

Treatment B (Fimasartan/Linagliptin)

Intervention Type DRUG

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Interventions

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Treatment A (Fimasartan, Linagliptin)

Co-administration of Fimasartan and Linagliptin

Intervention Type DRUG

Treatment B (Fimasartan/Linagliptin)

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

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. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
4. Medically healthy with no clinically significant medical history.

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 100/55 mmHg or greater than 140/100 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