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Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01581788
First received: April 4, 2012
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure the safety of 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: Open Label, Balanced, Randomized, Single-dose, Crossover Oral Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories, in Healthy Subjects Under Fed Conditions.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Area under curve (AUC) [ Time Frame: Pre-dose 1 hour, 1.50, 3, 4.50, 6, 7.50, 9, 10.50, 12, 13.50, 15, 16.50, 18, 19.50, 21, 22.50, 24, 25.50, 27, 32, 36, 48, 60, 72, 96 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Divalproex Sodium ER Tablets, 500 mg
Divalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited
 Drug: Divalproex Sodium
Divalproex Sodium ER Tablets, 500 mg
Other Name: Depakote
Active Comparator: Depakote ER Tablets, 500 mg
Depakote ER Tablets, 500 mg of Abbott Laboratories
 Drug: Divalproex Sodium
Divalproex Sodium ER Tablets, 500 mg
Other Name: Depakote

Detailed Description:

Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Divalproex Sodium Extended Release Tablets 500 mg of Dr. Reddy's Laboratories Limited, and Depakote ER 500 mg mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The subjects were selected for study participation, if they met the following criteria:

  1. Subjects aged between 18 and 45 years (both inclusive).
  2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.
  4. Subjects having normal 12-lead electrocardiogram (ECG).
  5. Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 6 months prior to the dosing of Period 01.
  6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  7. Subjects having negative alcohol breath test.
  8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

Exclusion Criteria:

The subjects were excluded from the study, if they met any of the following criteria:

  1. Hypersensitivity to Divalproex or related class of drugs.
  2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
  3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
  4. History or presence of significant alcoholism or drug abuse.
  5. History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
  6. History or presence of asthma, urticaria or other significant allergic reactions.
  7. History or presence of significant gastric and/or duodenal ulceration.
  8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  9. History or presence of cancer.
  10. Difficulty with donating blood.
  11. Difficulty in swallowing solids like tablets or capsules.
  12. Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
  13. Major illness during 3 months before screening.
  14. Participation in a drug research study within past 3 months.
  15. Donation of blood in the past 3 months before screening.
  16. Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing.
  17. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
  18. History or presence of significant easy bruising or bleeding.
  19. History or presence of significant recent trauma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581788

Locations
India
Veeda Clinical Research, India
Ahmedabad, Gujrat, India, 380 015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Gunjan Shah, MBBS Veeda Clinical Research, India
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01581788     History of Changes
Other Study ID Numbers: 10-vin-123
Study First Received: April 4, 2012
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

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

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 May 19, 2013