Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00849797
First received: February 20, 2009
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

The objective of this study is to compare the rate and extent of absorption of a test formulation of oxcarbazepine tablets and Trileptal® tablets administered as a 1 x 600 mg dose under fed conditions.


Condition Intervention Phase
Healthy
Drug: Oxcarbazepine
Drug: Trileptal®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Oxcarbazepine 600 mg Tablet and Trileptal® Following a 600 mg Dose in Healthy Subjects Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax - 10-hydroxy-carbazepine in Plasma [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - 10-Hydroxy-Carbazepine Metabolite [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - 10-Hydroxy-Carbazepine Metabolite [ Time Frame: Blood samples collected over 48 hour period ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2005
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxcarbazepine
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
Drug: Oxcarbazepine
600 mg Tablet
Active Comparator: Trileptal®
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
Drug: Trileptal®
600 mg Tablet

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Male or female, smoker or non-smoker, 18 years of age and older.
  • BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2

Exclusion Criteria

Subjects to whom any of the following applies will be excluded from the study:

  • Clinically significant illnesses or surgery within 4 weeks of the administration of study medication.
  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
  • Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
  • Positive testing for hepatitis B, hepatitis C or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90mmHg; or heart rate less than 50 or over 100 bpm) at screening.
  • History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
  • Regular use of alcohol within six months prior to the screening visit (more than 14 units of alcohol per [1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of 40% alcohol], or positive alcohol breath test at screening.
  • Use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reactions to heparin, oxcarbazepine, carbamazepine, or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the administration of the study medication.
  • Use of an investigational drug or participation on an investigation study within 30 days prior to dosing.
  • Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence or neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Difficulty to swallow study medication.
  • Smoking more than 25 cigarettes per day.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 30 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
  • 50 mL to 300 mL of whole blood within 30 days or
  • 301 mL to 500 mL of whole blood within 45 days or
  • more than 500 mL of whole blood within 56 days.
  • Consumption of food or beverages containing grapefruit (e.g. fresh, canned or frozen) within 7 days prior to administration of the study medication.
  • History or presence of atreoventricular (AV) block.
  • Difficulty fasting or consuming the standard meals.
  • Intolerance to venipunctures.
  • Clinically significant history of renal, hepatic, or cardiovascular, tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
  • Positive urine pregnancy test at screening.
  • Breast-feeding subject.
  • Female subjects of child-bearing potential having unprotected sexual intercourse with any non-sterile male partner within 14 days prior to study drug administration. Acceptable methods of contraception:
  • Intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration.
  • Condom or diaphragm + spermicide.
  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: NCT00849797

Locations
Canada, Quebec
SFBC Anapharm
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Richard Larouche, MD SFBC Anapharm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00849797     History of Changes
Other Study ID Numbers: 50370
Study First Received: February 20, 2009
Results First Received: July 2, 2009
Last Updated: September 9, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014