A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin 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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2017-11-21

Brief Summary

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The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.

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Detailed Description

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This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part A

Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days

Group Type EXPERIMENTAL

(fimasartan or linagliptin) x 7days

Intervention Type DRUG

Part A: fimasartan, Part B: linagliptin

(fimasartan and linagliptin) x 7days

Intervention Type DRUG

Part A \& Part B: Co-administration of fimasartan and linagliptin

Part B

Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days

Group Type EXPERIMENTAL

(fimasartan or linagliptin) x 7days

Intervention Type DRUG

Part A: fimasartan, Part B: linagliptin

(fimasartan and linagliptin) x 7days

Intervention Type DRUG

Part A \& Part B: Co-administration of fimasartan and linagliptin

Interventions

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(fimasartan or linagliptin) x 7days

Part A: fimasartan, Part B: linagliptin

Intervention Type DRUG

(fimasartan and linagliptin) x 7days

Part A \& Part B: Co-administration of fimasartan and linagliptin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 19-50 year-old healthy male.
2. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2
3. Subject who has no clinically significant medical history.
4. Subject whose informed consent is obtained and who is willing to comply with protocol.

Exclusion Criteria

1. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or \< 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or \< 70mmHg
2. Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
3. Creatinine clearance(CrCl) \< 80mL/min (using Cockcroft-Gault formula)
4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)
5. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes