A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Therapeutic Equivalency
Intervention: methylprednisolone (Drug); methylprednisolone (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
A study to determine whether a new formulation of methylprednisolone suspension is
bioequivalent to methylprednisolone tablets.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUCinf (area under the concentration curve to infinity)Cmax (maximum concentration)
Secondary outcome: AUC last (area under the concentration curve to last time point)Tmax (time at maximum concentration) Half-life
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
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 urine drug screen
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2012
Last updated: October 24, 2011
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