Overview

Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting Conditions

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Valproic Acid
Criteria
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.