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Completed

NCT Number: NCT01806363

Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook national university hospital Clionical center

Daegu, Gyeongsangbuk-do, 700-721, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects
  • Age(yr)between 20 and 50
  • Signed written informed consent

Exclusion criteria

  • Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive.
  • History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic.
  • History of drug and/or alcohol abuse
  • Over 10 tobaccos a day
  • Other condition which in the opinion of the investigator preclude enrollment into the study

Treatment and study plan

Telmisartan 80mg

Drug

Chlorthalidone 25mg

Drug

Primary outcomes

  1. Part A : AUC, Cmax of Telmisartan

    Time frame: Over a 24-hour sampling period

  2. Part B : AUC, Cmax of Chlorthalidone

    Time frame: Over a 24-hour sampling period

Secondary outcomes

  1. Part A : Cmin, tmax, CL/F of Telmisartan

    Time frame: Over a 24-hour sampling period

  2. Part B : Cmin, tmax, CL/F of Chlorthalidone

    Time frame: Over a 24-hour sampling period

Sponsors and collaborators

Lead sponsor

HanAll BioPharma Co., Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2013
Registry last updated
Feb 25, 2014

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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