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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.

Study Description
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Brief Summary:
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan 80mg Drug: Chlorthalidone 25mg Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.
Study Start Date : November 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Part A: Telmisartan, Chlorthalidone + Telmisartan
telmisartan 80mg : multiple dose administered orally chlorthalidone 25mg : multiple dose administered orally
 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
 Drug: Telmisartan 80mg
Drug: Chlorthalidone 25mg


Outcome Measures
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Primary Outcome Measures :
  1. Part A : AUC, Cmax of Telmisartan [ Time Frame: Over a 24-hour sampling period ]
  2. Part B : AUC, Cmax of Chlorthalidone [ Time Frame: Over a 24-hour sampling period ]

Secondary Outcome Measures :
  1. Part A : Cmin, tmax, CL/F of Telmisartan [ Time Frame: Over a 24-hour sampling period ]
  2. Part B : Cmin, tmax, CL/F of Chlorthalidone [ Time Frame: Over a 24-hour sampling period ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806363


Locations
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Korea, Republic of
Kyungpook national university hospital Clionical center
Daegu, Gyeongsangbuk-do, Korea, Republic of, 700-721
Sponsors and Collaborators
HanAll BioPharma Co., Ltd.
Investigators
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Principal Investigator: Young Ran Yoon, Associate Professor KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01806363    
Other Study ID Numbers: HTECHL12I_1
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014
Keywords provided by HanAll BioPharma Co., Ltd.:
Pharmacokinetics
Safety
Male
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Chlorthalidone
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators