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

Boryung Pharmaceutical Co., Ltd39 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

(fimasartan or linagliptin) x 7daysDRUG

Part A: fimasartan, Part B: linagliptin

(fimasartan and linagliptin) x 7daysDRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Kyungpook National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

[Part A] AUC of fimasartan

\[Part A\] Area under the curve(AUC) of fimasartan in steady state

Time frame: 0~24 hour after drug administration

[Part A] Cmax of fimasartan

\[Part A\] Cmax of fimasartan in steady state

Time frame: 0~24 hour after drug administration

[Part B] AUC of Linagliptin

\[Part B\] Area under the curve(AUC) of Linagliptin in Steady State

Time frame: 0~24 hour after drug administration

[Part B] Cmax of linagliptin

\[Part B\] Cmax of linagliptin in steady state

Time frame: 0~24 hour after drug administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.