At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Mycophenolate Mofetil +1 moredrug
Likely dose
Mycophenolate Mofetil 500 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 Single-Dose, Replicate, Comparative Bioavailability Study of Two Formulations of Mycophenolate Mofetil 500 mg Tablets Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Mycophenolate Mofetil and CellCept® Tablets for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The objective of this study was to evaluate the comparative bioavailability between Mycophenolate Mofetil 500 mg Tablets (test) and CellCept® 500 mg tablets (reference), after a single-dose in healthy subjects under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
Primary CompletionAug 2006
First PostedMay 2009
TodayJul 2026
First PostedMay 25, 2009
Enrollment StartJul 1, 2006
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago
Interventions
Mycophenolate Mofetildrug
Mycophenolate Mofetil Tablet 500 mg
CellCept® Tabletsdrug
CellCept® Tablets, 500 mg