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Completed

NCT Number: NCT02152969

Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

To evaluate Drug-drug interaction

Completed

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, South Korea

About this study

The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

Exclusion criteria

  • History of and clinically significant disease psychiatric, or malignancy.
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
  • Administration of other investigational products within 3 months prior to the first dosing.
  • Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
  • Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Treatment and study plan

Telmisartan

Drug

Amlodipine

Drug

Chlorthalidone

Drug

Primary outcomes

  1. AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone

    Time frame: Totally 28points for 24 hours

Secondary outcomes

  1. Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone

    Time frame: Totally 28points for 24 hours

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 2, 2014
Registry last updated
Nov 19, 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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