WithdrawnPhase 1

A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions

0Started 2011-10-14

Plain-language summary

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

Who can participate

Age range21 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 possible affecting drug absorption (eg, gastectomy). * A positive urine drug screen.

What they're measuring

AUCinf (area under the concentration time curve to infinity)

Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

Cmax (maximum concentration)

Timeframe: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

Trial details

NCT IDNCT01405170

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10-28

View on ClinicalTrials.gov More Therapeutic Equivalency trials