Drug Interaction Study of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

August 8, 2018 updated by: Boryung Pharmaceutical Co., Ltd

An Open-label, Randomized, Single Dose, 6-Sequence, 3-Period, Cross-over Study to Evaluate a Drug Interaction Between Fixed-dose Combination of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male Subjects

The purpose of this study is to evaluate the Drug interaction and safety of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy Male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • A healthy Male 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
Other: Arm1(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Names:
  • FAH
Other: Arm2(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Names:
  • FAH
Other: Arm3(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Names:
  • FAH
Other: Arm4(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Names:
  • FAH
Other: Arm5(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Names:
  • FAH
Other: Arm6(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Names:
  • FAH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 0~48hours after medication
Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma
0~48hours after medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCt
Time Frame: 0~48hours after medication
AUCt(Area under the curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine, Hydrochlorothiazide
0~48hours 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: Eun-Young Kim, Inje University

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)

December 15, 2017

Primary Completion (Actual)

January 16, 2018

Study Completion (Actual)

January 30, 2018

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

December 29, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR1010

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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