Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Keppra · 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,...
Keppra is the brand name for levetiracetam, a small molecule drug being studied in healthy volunteers. The clinical trials listed for Keppra are bioavailability studies conducted under fasting and non-fasting conditions, which are typical for assessing how the drug is absorbed and processed in the body.
Keppra is developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is being studied in Phase 1 clinical trials.
Keppra is in Phase 1 clinical development. All four clinical trials listed for Keppra are Phase 1 studies, and they have all been completed. Keppra is an investigational drug in this context, and it is not approved for any medical use based on the available information.
Keppra has been studied in four completed Phase 1 clinical trials. These include NCT00849485 and NCT00849862, which tested 750 mg tablets under non-fasting and fasting conditions in Canada, and NCT00859430 and NCT00859521, which tested 1000 mg tablets under non-fasting and fasting conditions in the United States.
Yes, Keppra is the brand name for levetiracetam. The clinical trials for Keppra are titled with levetiracetam, such as "Levetiracetam 750 mg Tablets Under Non-Fasting Conditions" and "Levetiracetam 1000 mg Under Fasting Conditions."