NCT01405131

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2012

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

July 25, 2011

Last Update Submit

October 27, 2018

Conditions

Therapeutic Equivalency

Keywords

bioequivalence studymethylprednisolonesuspensiontablets

Outcome Measures

Primary Outcomes (2)

  • AUCinf (area under the concentration curve to infinity)

    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

  • Cmax (maximum concentration)

    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

Secondary Outcomes (3)

  • AUC last (area under the concentration curve to last time point)

    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

  • Tmax (time at maximum concentration)

    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

  • Half-life

    0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

Study Arms (2)

methylprednisolone suspension

EXPERIMENTAL
Drug: methylprednisolone

methylprednisolone tablets

ACTIVE COMPARATOR
Drug: methylprednisolone

Interventions

methylprednisoloneDRUG

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

methylprednisolone suspension

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 29, 2011

Study Start

January 1, 2012

Primary Completion

February 20, 2012

Study Completion

February 20, 2012

Last Updated

October 30, 2018

Record last verified: 2018-10