Trials / Completed
CompletedNCT00985348
Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)
Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration in healthy Japanese subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levetiracetam (Keppra) | Test Drug : Levetiracetam dry syrup Reference Drug : 500 mg oral tablets of Levetiracetam. Frequency: Single Dose |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2009-09-28
- Last updated
- 2012-05-16
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00985348. Inclusion in this directory is not an endorsement.