Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 443 for:    Hydrochlorothiazide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390465
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Drug-Drug Interaction Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Arm1(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Name: FAH

Arm2(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Name: FAH

Arm3(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Name: FAH

Arm4(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Name: FAH

Arm5(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Name: FAH

Arm6(N=6)
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Drug: Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
Other Name: FAH




Primary Outcome Measures :
  1. Cmax [ Time Frame: 0~48hours after medication ]
    Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390465


Locations
Layout table for location information
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: Eun-Young Kim Inje University

Layout table for additonal information
Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03390465     History of Changes
Other Study ID Numbers: BR1010
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydrochlorothiazide
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors