Biological Availability Clinical Trial
Official title:
A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, Crossover Bioavailability Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/Ml to Methylprednisolone 32 Mg Tablet Under Fasted Conditions
Verified date | May 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 55 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Singapore | Pfizer Investigational Site | Singapore |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hours (hrs) post-dose | No |
Primary | Maximum Observed Plasma Concentration (Cmax) | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose | No | |
Secondary | 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 | No | |
Secondary | Plasma Decay Half-life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 12, 16 and 24 hrs post-dose | No |
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