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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03250052

Enrollment

Registered

2017-08-15

Start date

2017-08-14

Completion date

2017-11-21

Last updated

2018-01-18

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

Conditions

Hypertension

Keywords

Fimasartan

Brief summary

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

Detailed description

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

Interventions

DRUG(fimasartan or linagliptin) x 7days

Part A: fimasartan, Part B: linagliptin

DRUG(fimasartan and linagliptin) x 7days

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Inclusion Criteria (Total: 5): 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. 2\.

Exclusion criteria

(Total: 19): 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).

Design outcomes

Primary

Measure	Time frame	Description
[Part A] AUC of fimasartan	0~24 hour after drug administration	\[Part A\] Area under the curve(AUC) of fimasartan in steady state
[Part A] Cmax of fimasartan	0~24 hour after drug administration	\[Part A\] Cmax of fimasartan in steady state
[Part B] AUC of Linagliptin	0~24 hour after drug administration	\[Part B\] Area under the curve(AUC) of Linagliptin in Steady State
[Part B] Cmax of linagliptin	0~24 hour after drug administration	\[Part B\] Cmax of linagliptin in steady state

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026