Status:
COMPLETED
Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
Lead Sponsor:
Yonsei University
Conditions:
Essential Hypertension
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful informa...
Eligibility Criteria
Inclusion
- Adult subjects 20-50 years of age
- Above 55Kg and within ±20% ideal body weight
- Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) \< 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) \< 100mmHg
- Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
- Subjects who wrote informed consent
Exclusion
- Subjects who are suspected to have acute disease
- Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
- Subjects who have gastrointestinal history
- Subjects whose heartrate is less than 60
- Subject who suspected to orthostatic hypotension
- Subjects who have clinically significant allergy disease
- Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
- Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
- Subjects who have past history of drug abuse and positive in drug screening test
- Subjects who donate whole blood within 60 days and platelet within 30days.
- Subjects taking St John's wort or CYP inhibitor and inducer
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01198249
Start Date
September 1 2010
End Date
March 1 2011
Last Update
March 28 2011
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 120-752