Oxcarbazepine 600 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00850174
First received: February 20, 2009
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a single-dose in healthy subjects under fasting 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: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg 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 - 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: 60
Study Start Date: April 2005
Study Completion Date: May 2005
Primary Completion Date: May 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:

  • Healthy, non-smoking male and female subjects, 18 years of age or older.
  • BMI greater than or equal to 19 and less than or equal to 30.
  • Negative for:

    • HIV.
    • Hepatitis B surface antigen and Hepatitis C antibody.
    • Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
    • Urine cotinine test
    • Serum HCG consistent with pregnancy (females only)
  • No significant diseases or clinically significant findings in a physical examination.
  • No clinically significant abnormal laboratory values.
  • No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
  • Be informed of the nature of the study and given written consent prior to receiving any study procedure.
  • Females who participate in this study are:

    • unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy or,
    • willing to remain abstinent [not engage in sexual intercourse] or,
    • willing to use an effective method of double-barrier birth control [partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD].
  • Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

  • Known history or presence of any clinically significant medical condition.
  • Known or suspected carcinoma.
  • Known history or presence of:

    • Hypersensitivity or idiosyncratic reaction to oxcarbazepine and/or any other drug substances with similar activity.
    • Alcoholism within the last 12 months.
    • Drug dependence and/or substance abuse.
    • Use of tobacco or nicotine-containing products within the last 6 months.
  • On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
  • Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
  • Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
  • Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
  • Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
  • Requirement of any medication (prescription, hormonal contraceptive and/or over-the-counter) on a routine basis, with the exception of nutritional supplements and/or occasional use of common analgesics.
  • Difficulty fasting or consuming the standard meals.
  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: NCT00850174

Locations
Canada, Ontario
Pharma Medica Research Inc.
Toronto, Ontario, Canada, M1R 5A3
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Xueyu (Eric) Chen, MD Pharma Medica Research Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00850174     History of Changes
Other Study ID Numbers: 2005-917
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 September 18, 2014