Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levetiracetam · 4 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Levetiracetam | EXPERIMENTAL | Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period |
| Keppra® | ACTIVE_COMPARATOR | Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Levetiracetam | DRUG | 1000 mg Tablet |
| Keppra® | DRUG | 1000 mg Tablet |
Inclusion Criteria All subjects must satisfy the following criteria to be considered for study participation: * Subject must be male or non-pregnant, non-breast-feeding female * Subject must be at least 18 years of age * Subject must have a Body Mass Index (BMI) between 19 and 30 kg/m2, inclusive,...
Levetiracetam is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It is being studied in Phase 1 clinical development. The specific therapeutic indications for this program are not publicly disclosed. Levetiracetam has been evaluated in four completed Phase 1 trials involving a total of 96 participants.
Levetiracetam targets CACNA1B and SV2A. It is classified as a blocker. CACNA1B is a voltage-gated calcium channel, and SV2A is a synaptic vesicle glycoprotein. Both targets are associated with neuronal signaling. The drug is a small molecule modality.
Levetiracetam is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical development program for this asset.
Levetiracetam is in Phase 1 clinical development. All four of its listed trials are Phase 1 studies, and all four have been completed. There are currently no active trials for this program. The trials enrolled a total of 96 participants.
Levetiracetam has been studied in four completed Phase 1 trials: NCT00859521 and NCT00859430, conducted in the United States, and NCT00849862 and NCT00849485, conducted in Canada. These trials evaluated levetiracetam at 1000 mg and 750 mg under fasting and non-fasting conditions in healthy adult volunteers.
Yes. The levetiracetam Phase 1 trials were randomized and used active-controlled designs. They were not double-blind. All four trials enrolled healthy volunteers aged 18 years and older, with enrollment ranging from 22 to 30 participants per study.