Trials / Completed
CompletedNCT01355068
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Epanutin Infatabs 50 mg (Sourced From Germany) Verses Dilantin Infatabs 50 mg (Sourced From Australia) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Epanutin Infatabs (Phenytoin) | Chewable Tablet, 50 mg, Single dose |
| DRUG | Dilantin Infatabs (Phenytoin) | Chewable Tablet, 50 mg, Single dose |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2011-05-17
- Last updated
- 2021-01-28
- Results posted
- 2011-12-14
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT01355068. Inclusion in this directory is not an endorsement.