Steady-State Bioequivalence Study of Extended Phenytoin Sodium Capsules (100 mg; Mylan) and Dilantin® Kapseals® (100 mg; Pfizer) in Healthy Adult Volunteers

NCT00647621 Phase 1 COMPLETED

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.

Details

Lead sponsor	Mylan Pharmaceuticals Inc
Phase	Phase 1
Status	COMPLETED
Enrolment	72
Start date	2005-10
Completion	2005-12

Conditions

• Healthy

Interventions

• Extended Phenytoin Sodium Capsules 100 mg
• Dilantin® Kapseals® 100 mg

Primary outcomes

• Bioequivalence — within 30 days

Countries

United States