At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
methylprednisolone +2 moredrug
Likely dose
methylprednisolone 4 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 Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions
In Brief
A Phase 1 clinical trial evaluating methylprednisolone for Biological Availability. Completed, enrolled 24 participants across 1 site.
Detailed Summary
A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiological Availability
CountriesSingapore
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
Primary CompletionDec 2010
First PostedDec 2010
TodayJul 2026
First PostedDec 28, 2010
Enrollment StartNov 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.5 years ago
Interventions
methylprednisolonedrug
powder for oral suspension 4 mg/mL single dose (8 mL)
methylprednisolonedrug
powder for oral suspension 4 mg/mL singe dose (8 ml)
methylprednisolonedrug
tablet 32 mg single dose