Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

NCT00849797 | Completed Phase 1 Results

• 1 other identifier: 50370
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma

  Bioequivalence based on Cmax

  Blood samples collected over 48 hour period

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

  Bioequivalence based on AUC0-inf

  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

  Bioequivalence based on AUC0-t

  Blood samples collected over 48 hour period

Secondary Outcomes (3)

• Cmax - 10-hydroxy-carbazepine in Plasma

  Blood samples collected over 48 hour period

• AUC0-inf - 10-Hydroxy-Carbazepine Metabolite

  Blood samples collected over 48 hour period

• AUC0-t - 10-Hydroxy-Carbazepine Metabolite

  Blood samples collected over 48 hour period

Study Arms (2)

Oxcarbazepine

EXPERIMENTAL

Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period

Drug: Oxcarbazepine

Trileptal®

ACTIVE COMPARATOR

Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period

Drug: Trileptal®

Interventions

Oxcarbazepine DRUG

600 mg Tablet

Oxcarbazepine

Trileptal® DRUG

600 mg Tablet

Trileptal®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

SFBC Anapharm

Montreal, Quebec, H3X 2H9, Canada

Location

MeSH Terms

Interventions

Oxcarbazepine

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Richard Larouche, MD

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 24, 2009
• Study Start: July 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: August 19, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

CA (1)