Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Sumatriptan Succinate; Drug: Imitrex®

• Registration Number: NCT00847405
• Lead Sponsor: Teva Pharmaceuticals USA

Brief 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

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-18
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Sumatriptan Succinate	-
2	Imitrex®	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	Blood samples collected over a 12 hour period.	Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Blood samples collected over a 12 hour period.	Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Blood samples collected over a 12 hour period.	Bioequivalence based on AUC0-inf.

Trial Locations

Locations (1)

Biovail Contract Research; 🇨🇦 Toronto, Ontario, Canada