A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

Boryung

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: (fimasartan and linagliptin) x 7days; Drug: (fimasartan or linagliptin) x 7days

Study type: Interventional

Funder types: Industry

Identifiers

NCT03250052

BR-FLC-CT-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 39 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria (Total: 5):

2. 19-50 year-old healthy male.

3. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2

4. Subject who has no clinically significant medical history.

5. Subject whose informed consent is obtained and who is willing to comply with protocol.

6. Exclusion Criteria (Total: 19):

7. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or < 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or < 70mmHg

8. Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

9. Creatinine clearance(CrCl) < 80mL/min (using Cockcroft-Gault formula)

10. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)

11. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Part A

Experimental group

Description:

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

Treatment:

Drug: (fimasartan and linagliptin) x 7days

Drug: (fimasartan or linagliptin) x 7days

Part B

Experimental group

Description:

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

Treatment:

Drug: (fimasartan and linagliptin) x 7days

Drug: (fimasartan or linagliptin) x 7days