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

A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03609294

Enrollment

Registered

2018-08-01

Start date

2018-07-18

Completion date

2019-06-30

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension

Keywords

Fimasartan, Linagliptin

Brief summary

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.

Detailed description

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.

Interventions

DRUGTreatment A (Fimasartan, Linagliptin)

Co-administration of Fimasartan and Linagliptin

DRUGTreatment B (Fimasartan/Linagliptin)

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Cmax	Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration	Maximum concentration of drug in plasma of Fimasartan, Linagliptin
AUClast	Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration	Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026