Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Overview

Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.

Full Title of Study: “A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2013

Interventions

  • Drug: Telmisartan 80mg
  • Drug: Chlorthalidone 25mg

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • HanAll BioPharma Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Young Ran Yoon, Associate Professor, Principal Investigator, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER

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