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Completed

NCT Number: NCT03390465

Drug Interaction Study of Fimasartan/Amlodipine/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.

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Key information

Conditions

Drug-drug Interaction

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Drug

Fimasartan/Amlodipine combination drug, Hydrochlorothiazide

Other names: FAH

Primary outcomes

  1. Cmax

    Time frame: 0~48hours after medication

    Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2018
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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