A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01405170

Collaborator

(none)

Enrollment

Arms

4.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Equivalency	Drug: methylprednisolone Drug: methylprednisolone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions

Actual Study Start Date :

Oct 14, 2011

Anticipated Primary Completion Date :

Oct 28, 2011

Anticipated Study Completion Date :

Feb 20, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: methylprednisolone suspension	Drug: methylprednisolone constituted powder for oral suspension 4 mg/mL single dose at 32 mg
Active Comparator: methylprednisolone tablets	Drug: methylprednisolone tablets 32 mg single dose

Arm

Intervention/Treatment

Experimental: methylprednisolone suspension

Drug: methylprednisolone

constituted powder for oral suspension 4 mg/mL single dose at 32 mg

Active Comparator: methylprednisolone tablets

Drug: methylprednisolone

tablets 32 mg single dose

Outcome Measures

Primary Outcome Measures

AUCinf (area under the concentration time curve to infinity) [0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose]
Cmax (maximum concentration) [0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose]

Secondary Outcome Measures

AUClast (area under the concentration time curve to last time point) [0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose]
Tmax (time at maximum concentration) [0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose]
Half-life [0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male or female subjects between the ages of 21 and 55 years.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 45 kg (99 lbs).