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

October 19, 2018 updated by: Pfizer

Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 uring drug screen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: methylprednisolone suspension
Drug: methylprednisolone
constituted powder for oral suspension 4 mg/mL single dose at 16 mg
Drug: methylprednisolone
tablets 16 mg single dose
Active Comparator: methylprednisolone tablets
Drug: methylprednisolone
constituted powder for oral suspension 4 mg/mL single dose at 16 mg
Drug: methylprednisolone
tablets 16 mg single dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2012

Primary Completion (Anticipated)

February 20, 2012

Study Completion (Anticipated)

February 20, 2012

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0121007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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