DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Therapeutic Equivalency

Intervention: methylprednisolone (Drug); methylprednisolone (Drug)

Phase: Phase 1

Status: Withdrawn

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fed conditions.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

AUCinf (area under the concentration time curve to infinity)

Cmax (maximum concentration)

Secondary outcome:

AUClast (area under the concentration time curve to last time point)

Tmax (time at maximum concentration)

Half-life

Eligibility

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2011
Last updated: October 25, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017