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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01405170
First received: July 25, 2011
Last updated: October 25, 2011
Last verified: October 2011

July 25, 2011
October 25, 2011
October 2011
October 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Cmax (maximum concentration) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01405170 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Tmax (time at maximum concentration) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose ] [ Designated as safety issue: No ]
  • Half-life [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions
Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 mg/mL To Methylprednisolone 32 mg Tablet Under Fed Conditions

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Therapeutic Equivalency
  • Drug: methylprednisolone
    constituted powder for oral suspension 4 mg/mL single dose at 32 mg
  • Drug: methylprednisolone
    tablets 32 mg single dose
  • Experimental: methylprednisolone suspension
    Intervention: Drug: methylprednisolone
  • Active Comparator: methylprednisolone tablets
    Intervention: Drug: methylprednisolone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
16
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01405170
B0121008
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP