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A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 25, 2011
Last updated: October 24, 2011
Last verified: October 2011
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.

Condition Intervention Phase
Therapeutic Equivalency
Drug: methylprednisolone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder for Oral Suspension 4 mg/mL to Methylprednisolone 32 mg Tablet Under Fasted Conditions

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ] [ 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 ]

Estimated Enrollment: 16
Study Start Date: January 2012
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: methylprednisolone suspension Drug: methylprednisolone
constituted powder for oral suspension 4 mg/mL single dose at 32 mg
Active Comparator: methylprednisolone tablets Drug: methylprednisolone
tablets 32 mg single dose


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01405131

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01405131     History of Changes
Other Study ID Numbers: B0121006 
Study First Received: July 25, 2011
Last Updated: October 24, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
bioequivalence study

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on October 20, 2016