A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form

Phase 1

Completed

• Conditions: Biological Availability
• Interventions: Drug: methylprednisolone

• Registration Number: NCT01267201
• Lead Sponsor: Pfizer

Brief Summary

A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-28
• Status Verified: 2012-05
• Results First Submitted: 2012-05-24
• Results First Submitted QC: 2012-05-24
• Last Update Submitted: 2012-05-24
• Results First Posted: 2012-06-28
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2;
• a total body weight >45 kg (99 lbs).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
POS formulation #1	methylprednisolone	-
commercial tablet	methylprednisolone	-
POS formulation #2	methylprednisolone	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose	AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Maximum Observed Plasma Concentration (Cmax)	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose
Plasma Decay Half-life (t1/2)	0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore