At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 53 enrolled
Drug / intervention
Mycophenolate Mofetil +1 moredrug
Likely dose
Mycophenolate Mofetil 250 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, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Mycophenolate Mofetil and CellCept® for Healthy. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept® (mycophenolate mofetil) 250 mg administered to healthy subjects following an overnight fast of at least 10 hours.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
Primary CompletionNov 2006
First PostedJun 2009
TodayJul 2026
First PostedJun 1, 2009
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.1 years ago
Interventions
Mycophenolate Mofetildrug
250 mg Capsule
CellCept®drug
250 mg Capsule