A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: methylprednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405131

B0121006

Details and patient eligibility

About

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

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

methylprednisolone suspension

Experimental group

Treatment:

Drug: methylprednisolone

Drug: methylprednisolone

methylprednisolone tablets

Active Comparator group

Treatment:

Drug: methylprednisolone

Drug: methylprednisolone