Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

January 8, 2019 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 BR1010 and Co-administration of BR1010-1 and BR1010-2 in Healthy Volunteers

The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 100-744
        • Seoul National University Hospital

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

All

Description

Inclusion Criteria:

  • A healthy adults aged 19-50 years

Exclusion Criteria:

  • History or presence of clinically significant medical or psychiatric condition or disease
  • Hypersensitivity to ingredient of IP and other medication, food
  • Participation in any other study within 3months
  • History of whole blood donation within 2months and Apheresis 1month

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A

Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T)

There will be a 14 washout of days between the each period.
Drug: Treatment T
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Other Names:
  • FAH
Drug: Treatment R
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other Names:
  • FA/H
Experimental: Sequence B

Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R)

There will be a 14 washout of days between the each period.
Drug: Treatment T
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Other Names:
  • FAH
Drug: Treatment R
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other Names:
  • FA/H
Experimental: Sequence C

Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R)

There will be a 14 washout of days between the each period.
Drug: Treatment T
Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
Other Names:
  • FAH
Drug: Treatment R
Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
Other Names:
  • FA/H

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0~144hours after Medication
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
0~144hours after Medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf
Time Frame: 0~144hours after medication
"Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide
0~144hours after medication

Collaborators and Investigators

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

Sponsor

Boryung Pharmaceutical Co., Ltd

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)

September 13, 2018

Primary Completion (Actual)

November 29, 2018

Study Completion (Actual)

December 27, 2018

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BR1010(BR-FAHC-CT-102)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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