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OpenTrials
Completed

NCT Number: NCT03629067

Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects

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.

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Key information

Conditions

Pharmacokinetics Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 100-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Treatment T

Drug

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

Other names: FAH

Treatment R

Drug

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Other names: FA/H

Primary outcomes

  1. Cmax

    Time frame: 0~144hours after Medication

    Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

Secondary outcomes

  1. AUCinf

    Time frame: 0~144hours after medication

    "Area under the plasma concentration versus time curve " of Fimasartan, Amlodipine, Hydrochlorothiazide

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Jan 10, 2019

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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