Phase 1
Completed N=26
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
Healthy
Source: ClinicalTrials.gov NCT01355068 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) — 21380.0; 21370.0 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
21380.0; 21370.0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
952.10; 976.50 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) |
21730.0; 21740.0 | — |
| SECONDARY Extrapolated Area Under the Curve (AUC Percent [%] Extrap) |
3.321; 3.198 | — |
| SECONDARY Plasma Decay Half Life (t1/2) |
14.380; 14.970 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
3.51; 4.00 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
- An informed consent document signed and dated by the subject.
Exclusion Criteria
- Evidence or history of clinically significant abnormalities.
- Any condition possibly affecting drug absorption (e.g. gastrectomy).
Data sourced from ClinicalTrials.gov (NCT01355068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.