- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01806363
Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone
February 24, 2014 updated by: HanAll BioPharma Co., Ltd.
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeongsangbuk-do
-
Daegu, Gyeongsangbuk-do, Korea, Republic of, 700-721
- Kyungpook national university hospital Clionical center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Part A: Telmisartan, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
|
|
Active Comparator: Part B: Chlorthalidone, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A : AUC, Cmax of Telmisartan
Time Frame: Over a 24-hour sampling period
|
Over a 24-hour sampling period
|
Part B : AUC, Cmax of Chlorthalidone
Time Frame: Over a 24-hour sampling period
|
Over a 24-hour sampling period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A : Cmin, tmax, CL/F of Telmisartan
Time Frame: Over a 24-hour sampling period
|
Over a 24-hour sampling period
|
Part B : Cmin, tmax, CL/F of Chlorthalidone
Time Frame: Over a 24-hour sampling period
|
Over a 24-hour sampling period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Young Ran Yoon, Associate Professor, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
March 4, 2013
First Submitted That Met QC Criteria
March 5, 2013
First Posted (Estimate)
March 7, 2013
Study Record Updates
Last Update Posted (Estimate)
February 25, 2014
Last Update Submitted That Met QC Criteria
February 24, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Chlorthalidone
- Telmisartan
Other Study ID Numbers
- HTECHL12I_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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