NCT00649493

Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg

Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rabeprazole Sodium Tablets 20 mg	20mg, single dose fed
DRUG	Aciphex® Tablets 20 mg	20mg, single dose fed

Timeline

• Start date: 2003-05-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States