A bioequivalence study of single oral dose of three brands of 300mg Phenytoin sodium tablets marketed in India, on healthy Indian human volunteers

Three way, three period, cross over bioequivalence study of single oral dose of three brands of 300mg Phenytoin sodium tablets marketed in India, on healthy Indian human volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/05/001709

Enrollment

Registered

2011-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Tablet Phenytoin Brand name: Eptoin: one tablet contains 100 mg ,total 3 tablets Control Intervention1: Tablet Epsolin : one tablet contains 100 mg ,total 3 tablets Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: ?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

Exclusion criteria

Exclusion criteria: ?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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public Contactdr NIthya Gogtay

nil

njgogtay@hotmail.com02224133767

Outcome results