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Drug-drug Interaction Study (Telmisartan, Amlodipine, 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: NCT02152969
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Study Description
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Brief Summary:
To evaluate Drug-drug interaction

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan Drug: Amlodipine Drug: Chlorthalidone Phase 1

Detailed Description:
The purpose of this study is to evaluate the Drug-Drug(telmisartan, amlodipine and/ or chlorthalidone) interaction and safety in healthy adult volunteers.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Multiple-dose, Two-arm Clinical Study to Evaluate the Drug-drug Interaction and Safety of Telmisartan, Amlodipine and/or Chlorthalidone in Healthy Adult Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Part B
Arm to evaluate influence of Chlorthalidone on pharmacokinetics of amlodipine and telmisartan.
 Drug: Telmisartan
Drug: Amlodipine
Drug: Chlorthalidone
Part A
Arm to evaluate influence of amlodipine and telmisartan on pharmacokinetics of Chlorthalidone.
 Drug: Telmisartan
Drug: Amlodipine
Drug: Chlorthalidone


Outcome Measures
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Primary Outcome Measures :
  1. AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone [ Time Frame: Totally 28points for 24 hours ]

Secondary Outcome Measures :
  1. Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone [ Time Frame: Totally 28points for 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participant who has a body weight that is ≥55kg(male) or ≥50kg(female) with ideal body weight of 80-120% (ideal body weight)
  2. Who has not suffered from clinically significant disease
  3. Provision of signed written informed consent

Exclusion Criteria:

  1. History of and clinically significant disease psychiatric, or malignancy.
  2. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
  3. Administration of other investigational products within 3 months prior to the first dosing.
  4. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
  5. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
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): NCT02152969


Locations
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Korea, Republic of
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Investigators
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Principal Investigator: Dong Seok Yim The Catholic University of Korea
More Information
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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02152969    
Other Study ID Numbers: YH22162-101
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Chlorthalidone
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors