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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