A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
Sponsor
Pfizer (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01405157
Collaborator
(none)
0
2
1.6
Study Details
Study Description
Brief Summary
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions
Anticipated Study Start Date
:
Jan 1, 2012
Anticipated Primary Completion Date
:
Feb 20, 2012
Anticipated Study Completion Date
:
Feb 20, 2012
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: methylprednisolone suspension
|
Drug: methylprednisolone
constituted powder for oral suspension 4 mg/mL single dose at 16 mg
|
Active Comparator: methylprednisolone tablets
|
Drug: methylprednisolone
tablets 16 mg single dose
|
Outcome Measures
Primary Outcome Measures
- AUCinf (area under the concentration time 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 Outcome Measures
- AUClast (area under the concentration time 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts 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 uring drug screen.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01405157
Other Study ID Numbers:
- B0121007
First Posted:
Jul 29, 2011
Last Update Posted:
Oct 23, 2018
Last Verified:
Oct 1, 2018
Keywords provided by Pfizer
Additional relevant MeSH terms: