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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This study has been withdrawn prior to enrollment.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
  Purpose

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


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, Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 mg/mL To Methylprednisolone 32 mg Tablet Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: October 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT01405170

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01405170     History of Changes
Other Study ID Numbers: B0121008
Study First Received: July 25, 2011
Last Updated: October 25, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
bioequivalence study
methylprednisolone
suspension
tablets
fed

Additional relevant MeSH terms:
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014