NCT00647621

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Extended Phenytoin Sodium Capsules 100 mg	3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16
DRUG	Dilantin® Kapseals® 100 mg	3x100mg for 14 days, fasting conditions, continuing 2 days with dosing following high-fat breakfast on Day 16

Timeline

• Start date: 2005-10-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States