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

May 24, 2012 updated by: Pfizer

A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: POS formulation #1
Drug: methylprednisolone
powder for oral suspension 4 mg/mL single dose (8 mL)
Drug: methylprednisolone
powder for oral suspension 4 mg/mL singe dose (8 ml)
Drug: methylprednisolone
tablet 32 mg single dose
Experimental: POS formulation #2
Drug: methylprednisolone
powder for oral suspension 4 mg/mL single dose (8 mL)
Drug: methylprednisolone
powder for oral suspension 4 mg/mL singe dose (8 ml)
Drug: methylprednisolone
tablet 32 mg single dose
Active Comparator: commercial tablet
Drug: methylprednisolone
powder for oral suspension 4 mg/mL single dose (8 mL)
Drug: methylprednisolone
powder for oral suspension 4 mg/mL singe dose (8 ml)
Drug: methylprednisolone
tablet 32 mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Plasma Decay Half-life (t1/2)
Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs 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

November 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (Estimate)

December 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0121005

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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