Trials / Completed
CompletedNCT00616681
Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fasting Conditions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Roxane Laboratories · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation compared with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, following a single 600 mg dose administered under fasting conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxcarbazepine |
Timeline
- Start date
- 2004-06-01
- Primary completion
- 2004-07-01
- Completion
- 2004-07-01
- First posted
- 2008-02-15
- Last updated
- 2018-01-23
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00616681. Inclusion in this directory is not an endorsement.