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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Biological Availability

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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POS formulation #1

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

powder for oral suspension 4 mg/mL single dose (8 mL)

POS formulation #2

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

powder for oral suspension 4 mg/mL singe dose (8 ml)

commercial tablet

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

tablet 32 mg single dose

Interventions

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methylprednisolone

powder for oral suspension 4 mg/mL single dose (8 mL)

Intervention Type DRUG

methylprednisolone

powder for oral suspension 4 mg/mL singe dose (8 ml)

Intervention Type DRUG

methylprednisolone

tablet 32 mg single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
* a total body weight \>45 kg (99 lbs).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes