Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

February 24, 2014 updated by: HanAll BioPharma Co., Ltd.

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between Telmisartan and Chlorthalidone in Healthy Male Volunteers.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, Korea, Republic of, 700-721
        • Kyungpook national university hospital Clionical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A : AUC, Cmax of Telmisartan
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period
Part B : AUC, Cmax of Chlorthalidone
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A : Cmin, tmax, CL/F of Telmisartan
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period
Part B : Cmin, tmax, CL/F of Chlorthalidone
Time Frame: Over a 24-hour sampling period
Over a 24-hour sampling period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HanAll BioPharma Co., Ltd.

Investigators

  • Principal Investigator: Young Ran Yoon, Associate Professor, KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTECHL12I_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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