Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
1 other identifier
interventional
60
1 country
1
Brief Summary
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hypertension
Started Nov 2012
Typical duration for phase_1 hypertension
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 4, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFebruary 25, 2014
February 1, 2014
7 months
March 4, 2013
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part A : AUC, Cmax of Telmisartan
Over a 24-hour sampling period
Part B : AUC, Cmax of Chlorthalidone
Over a 24-hour sampling period
Secondary Outcomes (2)
Part A : Cmin, tmax, CL/F of Telmisartan
Over a 24-hour sampling period
Part B : Cmin, tmax, CL/F of Chlorthalidone
Over a 24-hour sampling period
Study Arms (2)
Part A: Telmisartan, Chlorthalidone + Telmisartan
ACTIVE COMPARATORtelmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
Part B: Chlorthalidone, Chlorthalidone + Telmisartan
ACTIVE COMPARATORtelmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- Age(yr)between 20 and 50
- Signed written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook national university hospital Clionical center
Daegu, Gyeongsangbuk-do, 700-721, South Korea
Related Publications (1)
Seong SJ, Lim MS, Lee J, Ohk B, Gwon MR, Kim BK, Kim HJ, Yang DH, Lee HW, Kang WY, Yoon YR. Evaluation of a Pharmacokinetic Interaction between Telmisartan and Chlorthalidone in Healthy Male Adult Subjects. Clin Drug Investig. 2016 Aug;36(8):613-23. doi: 10.1007/s40261-016-0406-y.
PMID: 27206575DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Ran Yoon, Associate Professor
KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2013
First Posted
March 7, 2013
Study Start
November 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 25, 2014
Record last verified: 2014-02