Healthy
Conditions
Keywords
fimasartan, absolute bioavailability
Brief summary
Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects
Interventions
DRUGFimasartan
Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* age: 20 - 55 years * body weight: standard weight(Broca's index, Possible range is plus or minus 20percent) * written informed consent
Exclusion criteria
* known allergy to Fimasartan * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder * abnormal diet which could affect drug absorption or metabolism * positive drug or alcohol screening * smokers of 10 or more cigarettes per day * participation in a clinical trial during the last 90 days prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl, | PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr |
Countries
South Korea
Outcome results
None listed