A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2012-02-20

Brief Summary

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

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Detailed Description

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Conditions

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Therapeutic Equivalency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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methylprednisolone suspension

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

constituted powder for oral suspension 4 mg/mL single dose at 16 mg

methylprednisolone tablets

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

tablets 16 mg single dose

Interventions

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methylprednisolone

constituted powder for oral suspension 4 mg/mL single dose at 16 mg

Intervention Type DRUG

methylprednisolone

tablets 16 mg single dose

Intervention Type DRUG

Eligibility Criteria

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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).