A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01405131

Enrollment

Registered

2011-07-29

Start date

2012-01-01

Completion date

2012-02-20

Last updated

2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapeutic Equivalency

Keywords

bioequivalence study, methylprednisolone, suspension, tablets

Brief summary

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

Interventions

DRUGmethylprednisolone

constituted powder for oral suspension 4 mg/mL single dose at 32 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCinf (area under the concentration curve to infinity)	0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Cmax (maximum concentration)	0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

Secondary

Measure	Time frame
AUC last (area under the concentration curve to last time point)	0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Tmax (time at maximum concentration)	0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Half-life	0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026