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Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01581775
First received: April 4, 2012
Last updated: April 19, 2012
Last verified: April 2012

April 4, 2012
April 19, 2012
January 2011
January 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01581775 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions
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 Fasting Conditions

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 fasting conditions and to monitor adverse events and ensure the safety of subjects.

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 fasting conditions.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Divalproex Sodium
Divalproex Sodium ER Tablets, 500 mg
Other Name: Depakote
  • Experimental: Divalproex Sodium ER Tablets, 500 mg
    Divalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Divalproex Sodium
  • Active Comparator: Depakote ER Tablets, 500 mg
    Depakote ER Tablets, 500 mg of Abbott Laboratories
    Intervention: Drug: Divalproex Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
March 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01581775
10-VIN-122
Yes
Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Dr. Gunjan Shah, MBBS Veeda Clinical Research, India
Dr. Reddy's Laboratories Limited
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP