A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form

Pfizer

Status and phase: Completed; Phase 1

Conditions: Biological Availability

Treatments: Drug: methylprednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01267201

B0121005

Details and patient eligibility

About

A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.

Enrollment: 24 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
• a total body weight >45 kg (99 lbs).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

POS formulation #1

Experimental group

Treatment:

Drug: methylprednisolone

Drug: methylprednisolone

Drug: methylprednisolone

POS formulation #2

Experimental group

Treatment:

Drug: methylprednisolone

Drug: methylprednisolone

Drug: methylprednisolone

commercial tablet

Active Comparator group

Treatment:

Drug: methylprednisolone

Drug: methylprednisolone

Drug: methylprednisolone