A Single-Dose, Comparative Bioavailability Study of Two Formulations of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
Overview
- Phase
- Phase 1
- Intervention
- Oxcarbazepine
- Conditions
- Healthy
- Sponsor
- Teva Pharmaceuticals USA
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Oxcarbazepine
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Eligibility 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
- •Negative for:
- •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).
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.
Arms & Interventions
Oxcarbazepine
Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
Intervention: Oxcarbazepine
Trileptal®
Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
Intervention: Trileptal®
Outcomes
Primary Outcomes
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
Bioequivalence based on AUC0-t
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Oxcarbazepine
Time Frame: Blood samples collected over 48 hour period
Bioequivalence based on AUC0-inf
Cmax - Maximum Observed Concentration - Oxcarbazepine in Plasma
Time Frame: Blood samples collected over 48 hour period
Bioequivalence based on Cmax
Secondary Outcomes
- AUC0-t - 10-hydroxy-carbazepine Metabolite(Blood samples collected over 48 hour period)
- 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)