Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Phase 1

Completed

Brief Summary: 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.

Detailed Description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Recruitment & Eligibility

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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine	Blood samples collected over 48 hour period	Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine	Blood samples collected over 48 hour period	Bioequivalence based on AUC0-inf
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma	Blood samples collected over 48 hour period	Bioequivalence based on Cmax

Secondary Outcome Measures

Name	Time	Method
AUC0-t - 10-hydroxy-carbazepine Metabolite	Blood samples collected over 48 hour period	Results of metabolite for informational purposes only
Cmax - 10-hydroxy-carbazepine in Plasma	Blood samples collected over 48 hour period	Results of Metabolite for Informational Purposes Only
AUC0-inf - 10-hydroxy-carbazepine Metabolite	Blood samples collected over 48 hour period	Results of Metabolite for informational purposes only