Hypertension
Conditions
Brief summary
To evaluate Drug-drug interaction
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.
Interventions
DRUGTelmisartan
DRUGAmlodipine
DRUGChlorthalidone
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt ss, Cmax ss of telmisartan/amlodipine/chlorthalidone | Totally 28points for 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Cmin ss, tmax ss, t1/2 of telmisartan/amlodipine/chlorthalidone | Totally 28points for 24 hours |
Countries
South Korea
Outcome results
None listed