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

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/Amlodipine and Co-administration of Fimasartan and Amlodipine in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02920047

Enrollment

Registered

2016-09-30

Start date

2016-10-31

Completion date

2017-01-31

Last updated

2018-01-09

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 the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

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/Amlodipine and co-administration of Fimasartan and Amlodipine.

Interventions

DRUGFimasartan/Amlodipine

Treatment B

DRUGFimasartan + Amlodipine

Treatment A

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. 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 100/65 mmHg or greater than 140/90 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
Cmax and AUClast of Fimasartan, Amlodipine	Time Frame: 0~144 hour after medication

Outcome results

None listed

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