A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

Boryung Pharmaceutical Co., Ltd36 enrolled

Overview

The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

FimasartanDRUG

RosuvastatinDRUG

Fimasartan + RosuvastatinDRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Caucasian male 19-55 years of age. 2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening. 3. Medically healthy with no clinically significant medical history. 4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol. 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 90/60 mmHg or greater than 140/90 mmHg at screening. 4. Plasma donation within 7 days prior to the first dose of study drug. 5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

Outcomes

Primary Outcomes

Area Under the Concentration-time Curve

This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method

Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

Maximum Observed Concentration

This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.

Time to Reach Maximum Observed Plasma Concentration

This Outcome is the time it takes a drug to reach Cmax

Data from ClinicalTrials.gov

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