Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions
Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioavailability of Divalproex Sodium DR Tablets
 500 mg versus Depakote DR 500 mg tablets with a washout period of 10 days in healthy
 subjects.
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
 crossover, bioequivalence study of Divalproex sodium DR 500 mg tablets of Dr.Reddy's
 Laboratories Limited, Generics, India comparing with that of Depakote® DR (containing
 Divalproex sodium) 500 mg tablets of Abbott Laboratories PR Ltd., Barceloneta, PR, in
 healthy, adult, human subjects under fasting conditions.
Inclusion Criteria:

 Subjects must fulfill all of the following criteria to be considered for inclusion into
 this study:

 -  Subjects who will provide written informed consent.

 -  Subjects must be healthy, adult, human beings within 18-45 years of age (both
 inclusive)weighing at least 50 kg.

 -  Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as
 weight in Kg/height in m2

 -  Subjects must be of normal health as determined by medical history and physical
 examination performed within 21 days prior to the commencement of the study.

 -  Subjects whose screening laboratory values are within normal limits or considered by
 the physician/investigator to be of no clinical significance.

 -  Availability of the subject for the entire study period and willingness to adhere to
 the protocol requirements as evidenced by written informed consent.

 Exclusion Criteria:

 The subjects will be excluded based on the following criteria during screening and during
 the study

 -  Subjects incapable of understanding the informed consent.

 -  Subjects who have:

 -  Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg

 -  Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor
 deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the
 physician/investigator.

 -  Pulse rate below 50/min and above 100/min.

 -  History of hypersensitivity or idiosyncratic reaction to Divalproex sodium or any
 other related drugs.

 -  Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal
 function.

 -  Consumption of grapefruit for the past ten days prior to the dosing day until the
 completion of the study.

 -  Regular smoker who has a habit of smoking more than nine cigarettes per day and has
 difficulty in abstaining from smoking from 48 hours before dosing and during sampling
 period

 -  Subjects who have taken over the counter or prescribed medications and enzyme
 modifying or any systemic medication for during the last 7 and 30 days respectively
 before dosing.

 -  Subjects who have participated in any other clinical investigation using experimental
 drug/donated blood in past 90 days before the date of start of study.

 -  Subjects with clinically significant abnormalities (such as Laboratory Findings, ECG,
 X-Ray,Drugs of abuse, Alcohol etc.,) and/or with significant diseases (such as HIV,
 HCV, Syphilis,Hepatitis B etc.,).

 -  Female subjects who are pregnant or who are able (women with child bearing potential)
 to become pregnant during the study.