Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. FDA label
Oxcarbazepine · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Oxcarbazepine | EXPERIMENTAL | Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period |
| Trileptal® | ACTIVE_COMPARATOR | Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Oxcarbazepine | DRUG | 600 mg Tablet |
| Trileptal® | DRUG | 600 mg Tablet |
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 s...
Oxcarbazepine is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in pharmacokinetic studies that assess how the body processes the 600 mg tablet formulation under different conditions.
Oxcarbazepine is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetic profile in healthy adult participants.
Oxcarbazepine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, both involving healthy volunteers, with a total enrollment of 180 participants.
Oxcarbazepine has two completed Phase 1 clinical trials. NCT00849797 evaluated the drug under non-fasting conditions in 120 healthy participants in Canada. NCT00850174 evaluated the drug under fasting conditions in 60 healthy participants in Canada. Both trials enrolled adults aged 18 years and older.