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Trial record 1 of 1 for:    NCT01405131
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A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets

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ClinicalTrials.gov Identifier: NCT01405131
Recruitment Status : Withdrawn
First Posted : July 29, 2011
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 29, 2011
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE January 1, 2012
Estimated Primary Completion Date February 20, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2011)
  • AUCinf (area under the concentration 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2011)
  • AUC last (area under the concentration 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
Official Title  ICMJE Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2 Period Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 32 Mg Tablet Under Fasted Conditions
Brief Summary A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Therapeutic Equivalency
Intervention  ICMJE
  • Drug: methylprednisolone
    constituted powder for oral suspension 4 mg/mL single dose at 32 mg
  • Drug: methylprednisolone
    tablets 32 mg single dose
Study Arms  ICMJE
  • Experimental: methylprednisolone suspension
    Intervention: Drug: methylprednisolone
  • Active Comparator: methylprednisolone tablets
    Intervention: Drug: methylprednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 27, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2011)
16
Estimated Study Completion Date  ICMJE February 20, 2012
Estimated Primary Completion Date February 20, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 urine drug screen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT01405131
Other Study ID Numbers  ICMJE B0121006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP