Phase 1
Completed N=24
A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form
Biological Availability
Source: ClinicalTrials.gov NCT01267201 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] — 1286.00; 1204.00; 1180.00 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
1286.00; 1204.00; 1180.00 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
289.00; 279.10; 246.20 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.00; 1.00; 2.00 | — |
| SECONDARY Plasma Decay Half-life (t1/2) |
2.43; 2.42; 2.45 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01267201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.