A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
Overview
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: February 20, 2012
Interventions
- Drug: methylprednisolone
- constituted powder for oral suspension 4 mg/mL single dose at 16 mg
- Drug: methylprednisolone
- tablets 16 mg single dose
Arms, Groups and Cohorts
- Experimental: methylprednisolone suspension
- Active Comparator: methylprednisolone tablets
Clinical Trial Outcome Measures
Primary Measures
- AUCinf (area under the concentration time curve to infinity)
- Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
- Cmax (maximum concentration)
- Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary Measures
- AUClast (area under the concentration time curve to last time point)
- Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
- Tmax (time at maximum concentration)
- Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
- Half-life
- Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 21 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Pfizer
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
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