NCT00847405

Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions

A Two-Way Crossover, Open-Label, Single-Dose, Fasting Bioequivalence Study of Sumatriptan Succinate 100 mg Tablets Versus Imitrex® 100 mg Tablets in Normal Healthy Non-Smoking Male and Female 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 fasting 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 Tablets
DRUG	Imitrex®	100 mg Tablet

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2009-02-19
• Last updated: 2009-09-11
• Results posted: 2009-08-18

Locations

1 site across 1 country: Canada