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

Boryung Pharmaceutical Co., Ltd67 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypertension Diabetes

Interventions

Treatment A (Fimasartan, Linagliptin)DRUG

Co-administration of Fimasartan and Linagliptin

Treatment B (Fimasartan/Linagliptin)DRUG

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Eligibility

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

Medical Language ↔ Plain English

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).

Locations (1)

Seoul National University Hospital

Seoul, Dahak-ro, South Korea

Outcomes

Primary Outcomes

Cmax

Maximum concentration of drug in plasma of Fimasartan, Linagliptin

Time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration

AUClast

Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin

Time frame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration

Data from ClinicalTrials.gov

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