drugset / Trial / NCT00647621

Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg

NCT00647621

Phase 1 Completed 72 enrolled Mylan Pharmaceuticals Inc
RandomizedCrossoverOpen-labelOther

Summary

The objective of this study was to investigate the steady-state bioequivalence of Mylan's extended phenytoin sodium capsules, 100mg (3x100mg), to Pfizer's Dilantin® Kapseals®, 100mg (3x100mg), under both fasting and fed conditions.

Timeline

Start
2005-10
Primary completion
2005-12
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenytoin Unknown 300 mg

Indications

No indication recorded.