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

January 7, 2018 updated by: Boryung Pharmaceutical Co., Ltd

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

The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A

Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B)

There will be a washout of 14 days between the each period.
Drug: Fimasartan/Amlodipine
Treatment B
Drug: Fimasartan + Amlodipine
Treatment A
Experimental: Sequence B

Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A)

There will be a washout of 14 days between the each period.
Drug: Fimasartan/Amlodipine
Treatment B
Drug: Fimasartan + Amlodipine
Treatment A
Experimental: Sequency C

Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A)

There will be a washout of 14 days between the each period.
Drug: Fimasartan/Amlodipine
Treatment B
Drug: Fimasartan + Amlodipine
Treatment A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax and AUClast of Fimasartan, Amlodipine
Time Frame: Time Frame: 0~144 hour after medication
Time Frame: 0~144 hour after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Investigators

  • Principal Investigator: Kyung-Sang Yu, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-FAC-CT-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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