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Completed

NCT Number: NCT02387554

Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

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Key information

Conditions

Hypertension(HTN) Cardiovascular Diseases Hypertension Vascular Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 19~45 years old
  • Healthy men

Exclusion criteria

  • Gastroentestinal disease affecting drug absorption

Treatment and study plan

HGP0904

Drug

Other names: amlodipine

HGP0608

Drug

Other names: losartan

HGP1405

Drug

Other names: chlorthalidone

Primary outcomes

  1. AUClast

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    AUClast(Area under the curve to the last measurable concentration)

  2. Cmax

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    Cmax(maxium concentration)

Secondary outcomes

  1. AUCinf

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    AUCinf(Area under the curve to infinity)

  2. Tmax

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    Tmax(Time to maximum concentration)

  3. T1/2

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    T1/2(Terminal elimination half-life),

  4. CL/F

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    CL/F(Apparent clearance)

  5. Vz/F

    Time frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr

    Vz/F(Apparent volume of distribution)

Other outcomes

  1. Number of Paticipants With Adverse Events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2015
Registry last updated
Jun 12, 2015

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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