Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
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
1 other identifier
interventional
66
1 country
1
Brief Summary
To evaluate Drug-drug interaction
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hypertension
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 29, 2014
CompletedFirst Posted
Study publicly available on registry
June 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 19, 2014
November 1, 2014
3 months
May 29, 2014
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone
Totally 28points for 24 hours
Secondary Outcomes (1)
Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone
Totally 28points for 24 hours
Study Arms (2)
Part B
OTHERArm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
Part A
OTHERArm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Seok Yim
The Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2014
First Posted
June 2, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
November 1, 2014
Last Updated
November 19, 2014
Record last verified: 2014-11