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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Status: Withdrawn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


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)



Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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