Hypertension
Conditions
Keywords
Pharmacokinetics, Safety, Male
Brief summary
Clinical trial to evaluate the pharmacokinetic interactions and safety between telmisartan and chlorthalidone.
Interventions
Sponsors
HanAll BioPharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A : AUC, Cmax of Telmisartan | Over a 24-hour sampling period |
| Part B : AUC, Cmax of Chlorthalidone | Over a 24-hour sampling period |
Secondary
| Measure | Time frame |
|---|---|
| Part A : Cmin, tmax, CL/F of Telmisartan | Over a 24-hour sampling period |
| Part B : Cmin, tmax, CL/F of Chlorthalidone | Over a 24-hour sampling period |
Countries
South Korea
Outcome results
None listed