NCT01267201

A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Biological Availability

Interventions

Type	Name	Description
DRUG	methylprednisolone	powder for oral suspension 4 mg/mL single dose (8 mL)
DRUG	methylprednisolone	powder for oral suspension 4 mg/mL singe dose (8 ml)
DRUG	methylprednisolone	tablet 32 mg single dose

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-12-28
• Last updated: 2012-06-28
• Results posted: 2012-06-28

Locations

1 site across 1 country: Singapore