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A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01405157
First received: July 25, 2011
Last updated: October 17, 2011
Last verified: October 2011
History of Changes
  Purpose

A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting 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 16 Mg Tablet Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

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: 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 16 mg
Active Comparator: methylprednisolone tablets Drug: methylprednisolone
tablets 16 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 possibly affecting drug absorption (eg, gastrectomy).
  • A positive uring drug screen.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405157

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01405157     History of Changes
Other Study ID Numbers: B0121007
Study First Received: July 25, 2011
Last Updated: October 17, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
bioequivalence study
methylprednisolone
suspension
tablets
fasting

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

ClinicalTrials.gov processed this record on May 16, 2013