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Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Oxcarbazepine (Drug); Trileptal® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Richard Larouche, MD, Principal Investigator, Affiliation: SFBC Anapharm

Summary

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine

Secondary outcome:

Cmax - 10-hydroxy-carbazepine in Plasma

AUC0-inf - 10-Hydroxy-Carbazepine Metabolite

AUC0-t - 10-Hydroxy-Carbazepine Metabolite

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

SFBC Anapharm, Montreal, Quebec H3X 2H9, Canada
Additional Information

Starting date: July 2005
Last updated: September 9, 2009

Page last updated: August 23, 2015

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