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A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions

Last updated on May 9, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Therapeutic Equivalency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any condition possible affecting drug absorption (eg, gastectomy).

- A positive urine drug screen.

NCT01405170
Pfizer
Withdrawn
A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions

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A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions
Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, Crossover Bioequivalence Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 mg/mL To Methylprednisolone 32 mg Tablet Under Fed Conditions
A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Therapeutic Equivalency
  • Drug: methylprednisolone
    constituted powder for oral suspension 4 mg/mL single dose at 32 mg
  • Drug: methylprednisolone
    tablets 32 mg single dose
  • Experimental: methylprednisolone suspension
    Intervention: Drug: methylprednisolone
  • Active Comparator: methylprednisolone tablets
    Intervention: Drug: methylprednisolone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
16
October 2011
October 2011   (Final data collection date for primary outcome measure)

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 possible affecting drug absorption (eg, gastectomy).
  • A positive urine drug screen.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Singapore
 
NCT01405170
B0121008
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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