NCT00650247

Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg

Single-Dose Food In Vivo Bioequivalence Study of Sumatriptan Succinate Tablets (100 mg; Mylan) to Imitrex® Tablets (100 mg; GlaxoSmithKline) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sumatriptan Succinate Tablets 100 mg	100mg, single dose fed
DRUG	Imitrex® Tablets 100 mg	100mg, single dose fed

Timeline

• Start date: 2004-11-01
• Primary completion: 2004-11-01
• Completion: 2004-12-01
• First posted: 2008-04-01
• Last updated: 2009-12-01

Locations

1 site across 1 country: United States