Bioequivalence test for Olmesartan medoxomil plus Hydrochlorothiazide
- Conditions
- Not Applicable
- Registration Number
- KCT0001025
- Lead Sponsor
- Kyung Hee University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 44
1. Subject is male and aged between 19 and 55 years of age (inclusive)
2. Subject has no clinically relevant findings in the physical examination (as judged by the investigator)
3. Subject has no clinically relevant abnormality in the clinical chemistry, hematology, or urinalysis
1. Subject is taking any inducers and inhibitors on drug-metabolizing enzymes (such as barbital)within 1 month.
2. Subject is taking any medication (excluding oral hormonal contraceptive) currently or within 10 days prior to the first day of dosing
3. Subject has a clinically relevant allergy (including the study drug)
4. Subject has a history of significant hypersensitivity (or allergy) to study drug
5. Subject has participated in another clinical trial of an investigational drug within the last 3 months
6. Suject has had a history of transient ischemic attack or stroke within the last 12 months
7. Subject is unable to read or write
8. Subject have genetic disorders (galatose intolerance, Lapp lactase deficiency, glucose-galatose malabsorption etc.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast for olmesartan medoxomil and hydrochlorothiazide;Cmax for olmesartan medoxomil and hydrochlorothiazide
- Secondary Outcome Measures
Name Time Method AUCinf for olmesartan medoxomil and hydrochlorothiazide;Tmax for olmesartan medoxomil and hydrochlorothiazide