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NCT01405131 Clinical Trial

A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

Therapeutic Equivalency Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01405131
Other study ID # B0121006
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date January 1, 2012
Est. completion date February 20, 2012

Study information
Verified date October 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 20, 2012
Est. primary completion date February 20, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• methylprednisolone
constituted powder for oral suspension 4 mg/mL single dose at 32 mg
• methylprednisolone
tablets 32 mg single dose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary AUCinf (area under the concentration curve to infinity) 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Primary Cmax (maximum concentration) 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary 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
Secondary Tmax (time at maximum concentration) 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary Half-life 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
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