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Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01806363
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
HanAll BioPharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 4, 2013
First Posted Date  ICMJE March 7, 2013
Last Update Posted Date February 25, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Part A : AUC, Cmax of Telmisartan [ Time Frame: Over a 24-hour sampling period ]
  • Part B : AUC, Cmax of Chlorthalidone [ Time Frame: Over a 24-hour sampling period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Part A : Cmin, tmax, CL/F of Telmisartan [ Time Frame: Over a 24-hour sampling period ]
  • Part B : Cmin, tmax, CL/F of Chlorthalidone [ Time Frame: Over a 24-hour sampling period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone
Official Title  ICMJE A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
Brief Summary Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Telmisartan 80mg
  • Drug: Chlorthalidone 25mg
Study Arms  ICMJE
  • Active Comparator: Part A: Telmisartan, Chlorthalidone + Telmisartan
    telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
    Interventions:
    • Drug: Telmisartan 80mg
    • Drug: Chlorthalidone 25mg
  • Active Comparator: Part B: Chlorthalidone, Chlorthalidone + Telmisartan
    telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
    Interventions:
    • Drug: Telmisartan 80mg
    • Drug: Chlorthalidone 25mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)		 60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy male subjects
  2. Age(yr)between 20 and 50
  3. Signed written informed consent

Exclusion Criteria:

  1. Known hypersensitivity to investigator product, thiazide, sulphonamide and other drugs or additive.
  2. History of any siginificant Sickness, Cardiovascular, Respiratory, Renal, Endocrine, Neurological, Psychic, Cancer, Gasstrointestinal, Hematologic.
  3. History of drug and/or alcohol abuse
  4. Over 10 tobaccos a day
  5. Other condition which in the opinion of the investigator preclude enrollment into the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01806363
Other Study ID Numbers  ICMJE HTECHL12I_1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party HanAll BioPharma Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE HanAll BioPharma Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Ran Yoon, Associate Professor KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER
PRS Account HanAll BioPharma Co., Ltd.
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP