None listed
Conditions
Interventions
Drug : The study design was a randomized sequence, open labeled, single dose and two-way crossover in healthy adult male volunteers. A total of 44 volunteers were to be randomly assigned to either one
each subject sequentially received a single oral dose of reference and test tablet with 7-day washout period. And all of the subjects were discharged after completed the study. Blood sample was collec
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUClast for olmesartan medoxomil and hydrochlorothiazide;Cmax for olmesartan medoxomil and hydrochlorothiazide | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf for olmesartan medoxomil and hydrochlorothiazide;Tmax for olmesartan medoxomil and hydrochlorothiazide | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Yim
Kyung Hee University Hospital
Outcome results
None listed