A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

Phase 1

Withdrawn

• Conditions: Therapeutic Equivalency
• Interventions: Drug: methylprednisolone

• Registration Number: NCT01405131
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-29
• Study Start: 2012-01-01
• Primary Completion: 2012-02-20
• Study Completion: 2012-02-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-27
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Exclusion Criteria

• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
methylprednisolone suspension	methylprednisolone	-
methylprednisolone tablets	methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
AUCinf (area under the concentration 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

Name	Time	Method
AUC last (area under the concentration 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