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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01132170
First received: May 26, 2010
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Divalproex Sodium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: August 2006
Study Completion Date: November 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Depakote DR 500 mg Tablets

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 fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132170

Locations
India
Bioserve Clinical Research Pvt. Ltd.,
Hyderabad, Andhra Pradesh, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mohanlal Siva Prasad Sayana Bioserve Clinical Research Pvt. Ltd.,
  More Information

No publications provided

Responsible Party: Indu Bhushan / Senior Director R&D, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01132170     History of Changes
Other Study ID Numbers: P-623/06-00
Study First Received: May 26, 2010
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Divalproex Sodium

Additional relevant MeSH terms:
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014