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WithdrawnNCT01405131Updated Oct 30, 2018

A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

A Phase 1 interventional study of methylprednisolone and methylprednisolone in Therapeutic Equivalency, sponsored by Pfizer. Withdrawn. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Therapeutic Equivalency

Keywords

  • bioequivalence study
  • methylprednisolone
  • suspension
  • tablets
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    methylprednisolone suspension

    Drug: methylprednisolone

  • Active comparator
    methylprednisolone tablets

    Drug: methylprednisolone

Interventions

  • Drugmethylprednisolone

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

  • Drugmethylprednisolone

    tablets 32 mg single dose

06

What researchers measure

Primary outcomes

  1. AUCinf (area under the concentration curve to infinity)

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

  2. Cmax (maximum concentration)

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

Secondary outcomes

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

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

  2. Tmax (time at maximum concentration)

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

  3. Half-life

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

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01405131
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jul 29, 2011
Start date
Jan 1, 2012
Primary completion
Feb 20, 2012 (estimated)
Completion
Feb 20, 2012 (estimated)
Last update
Oct 30, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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