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A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804

NCT01313793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-06-28

No results posted yet for this study

Summary

The study will determine if bioequivalence can be claimed between the proposed commericializable formulation and the current clinical formulation. Specifically, if the 90% confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration (CMax) are within the 80%-125% guidance limits.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Treatment A-B

Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period.

DRUG

Treatment B-A

Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01313793 on ClinicalTrials.gov