Trials / Completed
CompletedNCT01394224
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levetiracetam | Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose |
| DRUG | Levetiracetam | Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2011-07-14
- Last updated
- 2011-10-06
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01394224. Inclusion in this directory is not an endorsement.