Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Phase 1CompletedNCT01806363

HanAll BioPharma Co., Ltd.60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Telmisartan 80mgDRUG

Chlorthalidone 25mgDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Kyungpook national university hospital Clionical center

Daegu, Gyeongsangbuk-do, South Korea

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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