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Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Information source: HanAll BioPharma Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Telmisartan 80mg (Drug); Chlorthalidone 25mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: HanAll BioPharma Co., Ltd.

Official(s) and/or principal investigator(s):
Young Ran Yoon, Associate Professor, Principal Investigator, Affiliation: KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL, CLINICAL TRIAL CENTER

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Part A : AUC, Cmax of Telmisartan

Part B : AUC, Cmax of Chlorthalidone

Secondary outcome:

Part A : Cmin, tmax, CL/F of Telmisartan

Part B : Cmin, tmax, CL/F of Chlorthalidone

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

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

Locations and Contacts

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

Starting date: November 2012
Last updated: February 24, 2014

Page last updated: August 23, 2015

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