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

Information source: Yuhan Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Amlodipine (Drug); Chlorthalidone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Yuhan Corporation

Official(s) and/or principal investigator(s):
Dong Seok Yim, Principal Investigator, Affiliation: The Catholic University of Korea


To evaluate Drug-drug interaction

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone

Secondary outcome: Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone

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


Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Both.


Inclusion Criteria: 1. Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight) 2. Who has not suffered from clinically significant disease 3. Provision of signed written informed consent Exclusion Criteria: 1. History of and clinically significant disease psychiatric, or malignancy. 2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. 3. Administration of other investigational products within 3 months prior to the first dosing. 4. 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). 5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.

Locations and Contacts

The Catholic University of Korea Seoul St.Mary's Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: May 2014
Last updated: November 18, 2014

Page last updated: August 23, 2015

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