A bioequivalence study of single oral dose of three brands of 300mg Phenytoin sodium tablets marketed in India, on healthy Indian human volunteers
- Registration Number
- CTRI/2011/05/001709
- Lead Sponsor
- Abbott India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
?Weight range within 20% of the ideal body weight as per standard tables and Indian criteria.
?Age 18-45 years of male gender only.
?Patients willing to sign informed consent form before undergoing screening.
?Patients willing to undergo follow up for 2 ? 6 months.
?Physical examination ? all findings of physical examination are normal with no ongoing serious illness that may affect the outcome of the study.
?Biochemical and hematologic test values (done within 2 week of the study), urine examination, and ECG?all within normal limit
?Negative for Hbs Ag (Australia antigen) and HIV
?Agreement to abstain from caffeine on the day of the study and from alcohol and any other medication for 48 hours prior to entry into the study and during the course of the study
?History of intercurrent or concurrent diseases chronic alcohol consumption or drug addiction.
?History of chronic GI, renal, hepatic, cardiovascular, CNS, respiratory, infectious, or psychiatric diseases that affect the outcome of the study,
?History of allergy or hypersensitivity to phenytoin sodium, consumption of tobacco in any form, participation in a new drug study in the past 6 months and in a bioavailability or any study of a marketed drug in the past 3 months, donating blood in the past 3 months,
?Any drug intake in the past 15 days or intake of an enzyme-inducing agent in the past 30 days.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To calculate pharmacokinetic parameters such as Cmax, tmax, AUC0-t and compare it with comparator drugsTimepoint: blood will be collected at 0,1,2,3,4,5,6,8,10,12,24,36,48,60 and 72 hours and parameters will be collected at these time points
- Secondary Outcome Measures
Name Time Method nilTimepoint: nil