Clinical Trials Logo
  1. Home
  2. Seizure
  3. NCT00946751
  4. Details
NCT00946751 Clinical Trial

To Demonstrate the Relative Bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

Seizure Clinical Trial

Official title:
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam Tablets In Healthy Adults Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00946751
Other study ID # AA15241
Secondary ID
Status Completed
Phase Phase 1
First received July 24, 2009
Last updated March 27, 2017
Start date March 2004
Est. completion date March 2004

Study information
Verified date July 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To demonstrate the relative bioavailability of Sandoz Inc. and UCB Pharma, Inc (Keppra) 750 mg Levetiracetam tablets in healthy adult volunteers under fasting conditions.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2004
Est. primary completion date March 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

- Positive test results for HIV or hepatitis B or C.

- Treatment for drug or alcohol dependence.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Levetiracetam Tablets, 750 mg (Sandoz Inc.)

• Keppra (Levetiracetam) Tablets, 750 mg (UCB Pharma, Inc)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 10 days
See also
  Status Clinical Trial Phase
Completed NCT00021866 - Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy N/A
Completed NCT01417507 - Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery N/A
Completed NCT01123746 - Utility of Laboratory Testing for Children With Seizure in Emergency Department N/A
Completed NCT02926703 - Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure N/A
Completed NCT01796574 - Ketogenic Diet for Refractory Status Epilepticus N/A
Not yet recruiting NCT01436695 - Safety and Feasibility of Using Epicall for Monitoring Pre-seizure Biomarkers N/A
Recruiting NCT05746624 - Procedural Motor Memory in Long COVID-19 N/A
Terminated NCT02883712 - Study of Predictors of Response to Anti Epilepsy in Epilepsy
Completed NCT00880204 - Evaluation of Essential Surgical Skills-Emergency Maternal and Child Health Training N/A
Enrolling by invitation NCT02694094 - Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy
Completed NCT02426047 - Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy N/A
Completed NCT01834482 - Modified Atkins Diet Plus KetoCal for Adult Epilepsy N/A
Completed NCT01744301 - Acid Suppressing Drug Seizure Epidemiology Study N/A
Completed NCT01694524 - Nervous System Infections Among Patients With Febrile Seizure N/A
Terminated NCT01910129 - Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy N/A
Completed NCT00298532 - OPALS Pediatric Study N/A
Completed NCT01982812 - A Dose-Escalation, Safety and Feasibility Study of Enteral LVT for Seizure Control in Pediatric CM Phase 2
Completed NCT01660672 - Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria Phase 1/Phase 2
Completed NCT00285285 - Point of Care Device Use in the Pediatric Emergency Department N/A
Completed NCT01801072 - Seizure Prophylaxis in Aneurysm Repair Phase 4