Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00849797 |
Recruitment Status
:
Completed
First Posted
: February 24, 2009
Results First Posted
: August 18, 2009
Last Update Posted
: September 15, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Oxcarbazepine Drug: Trileptal® | Phase 1 |
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | July 2005 |
Actual Study Completion Date : | July 2005 |

Arm | Intervention/treatment |
---|---|
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
|
- Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma [ Time Frame: Blood samples collected over 48 hour period ]
- AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine [ Time Frame: Blood samples collected over 48 hour period ]
- 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 ]
- Cmax - 10-hydroxy-carbazepine in Plasma [ Time Frame: Blood samples collected over 48 hour period ]
- AUC0-inf - 10-Hydroxy-Carbazepine Metabolite [ Time Frame: Blood samples collected over 48 hour period ]
- AUC0-t - 10-Hydroxy-Carbazepine Metabolite [ Time Frame: Blood samples collected over 48 hour period ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849797
Canada, Quebec | |
SFBC Anapharm | |
Montreal, Quebec, Canada, H3X 2H9 |
Principal Investigator: | Richard Larouche, MD | SFBC Anapharm |
ClinicalTrials.gov Identifier: | NCT00849797 History of Changes |
Other Study ID Numbers: |
50370 |
First Posted: | February 24, 2009 Key Record Dates |
Results First Posted: | August 18, 2009 |
Last Update Posted: | September 15, 2009 |
Last Verified: | September 2009 |
Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
Oxcarbazepine Carbamazepine Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |
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 |