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

Primary Purpose

Therapeutic Equivalency

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
methylprednisolone
methylprednisolone
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Therapeutic Equivalency focused on measuring bioequivalence study, methylprednisolone, suspension, tablets, fed

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    methylprednisolone suspension

    methylprednisolone tablets

    Arm Description

    Outcomes

    Primary Outcome Measures

    AUCinf (area under the concentration time curve to infinity)
    Cmax (maximum concentration)

    Secondary Outcome Measures

    AUClast (area under the concentration time curve to last time point)
    Tmax (time at maximum concentration)
    Half-life

    Full Information

    First Posted
    July 25, 2011
    Last Updated
    October 27, 2018
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01405170
    Brief Title
    A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions
    Official Title
    Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fed Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    October 14, 2011 (Actual)
    Primary Completion Date
    October 28, 2011 (Anticipated)
    Study Completion Date
    February 20, 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Therapeutic Equivalency
    Keywords
    bioequivalence study, methylprednisolone, suspension, tablets, fed

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    methylprednisolone suspension
    Arm Type
    Experimental
    Arm Title
    methylprednisolone tablets
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolone
    Intervention Description
    constituted powder for oral suspension 4 mg/mL single dose at 32 mg
    Intervention Type
    Drug
    Intervention Name(s)
    methylprednisolone
    Intervention Description
    tablets 32 mg single dose
    Primary Outcome Measure Information:
    Title
    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
    Title
    Cmax (maximum concentration)
    Time Frame
    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Tmax (time at maximum concentration)
    Time Frame
    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
    Title
    Half-life
    Time Frame
    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0121008&StudyName=A%20Bioequivalence%20Study%20Comparing%20Methylprednisolone%20Suspension%20to%20Methylprednisolone%20Tablets%20Under%20Fed%20Conditions
    Description
    To obtain contact information for a study center near you, click here.

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

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