Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834639
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets)in healthy subjects under fasting conditions.


Condition Intervention Phase
Healthy
Drug: divalproex sodium
Drug: Depakote®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 500 mg Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: divalproex sodium
delayed-release 500 mg tablet
Active Comparator: 2 Drug: Depakote®
delayed-release 500 mg tablet

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Screening Demographics: All subjects selected for this study will be healthy men or women 18-65 years of age, inclusive, at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30.
  • Screening Procedures: Each subject will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.

The screening clinical laboratory procedures will include:

  • HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
  • CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
  • HIV antibody, hepatitis B surface antigen, hepatitis C antibody screens
  • URINALYSIS: by dipstick; full microscopic examination if dipstick positive
  • URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine
  • SERUM PREGNANCY SCREEN (female subjects only)
  • FOLLICLE STIMULATING HORMONE (FSH; female subjects only): verify postmenopausal status

If female and:

  • Is postmenopausal for at least 1 year with postmenopausal status defined as: > 60 years of age and amenorrheic for at least one year; if 60 years of age or younger, must also have a serum FSH level > 30 IU/L; or
  • Is surgically sterile for at least 6 months (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria

  • Subjects with a recent history of drug or alcohol addiction or abuse.
  • Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Subjects whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
  • Subjects demonstrating a positive drug abuse screen when screened for this study.
  • Female subjects demonstrating a positive pregnancy screen.
  • Female subjects who are currently breastfeeding.
  • Subjects with a history of allergic response(s) to divalproex sodium or related drugs.
  • Subjects with a history of clinically significant allergies including drug allergies.
  • Subjects with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Subjects who currently or report using tobacco products within 90 days of Period I dose administration.
  • Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  • Subjects who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  • Subjects who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  • Subjects who report receiving any investigational drug within 28 days prior to Period I dosing.
  • Subjects who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
  • Subjects who report an intolerance of direct venipuncture.
  • Subjects who report consuming an abnormal diet during the 28 days prior to Period I dosing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834639

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00834639     History of Changes
Other Study ID Numbers: R03-592
Study First Received: January 30, 2009
Results First Received: June 22, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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 September 16, 2014