Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed Conditions

An Open Label, Balanced, Randomized, 2-treatment, 2-period, 2-sequence, Single Dose, Crossover, Bioequivalence Study of Divalproex Sodium DR 500 mg Tablets and Depakote® DR 500 mg Under Fed 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Divalproex Sodium

Detailed Description

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 fed conditions.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 037
      • Bioserve Clinical Research Pvt. Ltd.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Divalproex Sodium DR Tablets 500 mg; Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited	Drug: Divalproex Sodium; Divalproex Sodium DR Tablets 500 mg; Other Names: Depakote DR 500 mg Tablets
Active Comparator: Depakote DR 500 mg Tablets; Depakote DR 500 mg Tablets of Abbott Laboratories PR Ltd.,	Drug: Divalproex Sodium; Divalproex Sodium DR Tablets 500 mg; Other Names: Depakote DR 500 mg Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	4 months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Mohanlal Siva Prasad Sayana, Bioserve Clinical Research Pvt. Ltd.,

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 27, 2010

Study Record Updates

• Last Update Posted (Estimate): June 14, 2010
• Last Update Submitted That Met QC Criteria: June 11, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Crossover; Divalproex Sodium
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: P-624/06-00