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

NCT ID: NCT01405170

Last Updated: 2018-10-30

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WITHDRAWN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

2011-10-14

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 fed 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 32 mg

methylprednisolone tablets

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

tablets 32 mg single dose

Interventions

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methylprednisolone

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

Intervention Type DRUG

methylprednisolone

tablets 32 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).

Exclusion Criteria

* Any condition possible affecting drug absorption (eg, gastectomy).
* A positive urine drug screen.
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0121008&StudyName=A%20Bioequivalence%20Study%20Comparing%20Methylprednisolone%20Suspension%20to%20Methylprednisolone%20Tablets%20Under%20Fed%20Conditions

To obtain contact information for a study center near you, click here.

Other Identifiers

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B0121008

Identifier Type: -

Identifier Source: org_study_id

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