NCT00846885

Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions

A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Sumatriptan Succinate, (100mg), Compared to and Equivalent Dose of a Commercially Available Reference Drug Product (Imitrex®, GlaxoSmithKline, USA) in 28 Fed, Healthy, Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fed conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sumatriptan Succinate	100 mg Tablet
DRUG	Imitrex®	100 mg Tablet

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-09-01
• Completion: 2004-10-01
• First posted: 2009-02-19
• Last updated: 2009-09-11
• Results posted: 2009-08-18

Locations

1 site across 1 country: United States