At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 28 enrolled
Drug / intervention
Sumatriptan Succinate +1 moredrug
Likely dose
Sumatriptan Succinate 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Sumatriptan Succinate and Imitrex® for Healthy. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2003
Primary CompletionMar 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartMar 1, 2003
Primary CompletionMar 1, 2003
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Sumatriptan Succinatedrug
100 mg Tablets
Imitrex®drug
100 mg Tablet