NCT01269281

Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions

Open Label, Randomized, Two Way Crossover, Comparative Evaluation of Relative Bioavailabilities of Two Formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories Limited, India)With the Reference Formulation Imitrex Tablets 100 mg (Glaxosmilthkine) in Healthy Adult Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects.

Detailed description

Open Label, Randomized, Two way crossover, comparative evaluation of relative bioavailability of two formulations of Sumatriptan Succinate Tablets 100 mg (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation Imitrex® 100 mg Tablet (Glaxosmithkline, USA)Under Fed Conditions in Healthy Human Adult Subjects. 50 healthy, adult, human male subjects were enrolled in the study and 43 subjects are completed the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sumatriptan	Sumatriptan Succinate Tablets 100 mg

Timeline

• Start date: 2005-07-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2011-01-04
• Last updated: 2011-01-04

Locations

1 site across 1 country: India