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 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.
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 fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
Primary CompletionSep 2004
Study CompletionOct 2004
First PostedFeb 2009
TodayJul 2026
First PostedFeb 19, 2009
Enrollment StartAug 1, 2004
Primary CompletionSep 1, 2004
Study CompletionOct 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Sumatriptan Succinatedrug
100 mg Tablet
Imitrex®drug
100 mg Tablet