Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers

NCT00782600 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2009-06-09

No results posted yet for this study

Summary

This study is to test the idea that a controlled release formulation of CE-224,535 may allow for less frequent dosing and exposure to lower levels of drug than an immediate release formulation.

Conditions

Interventions

DRUG

suspension IR

50 mg IR suspension once daily for one day

DRUG

CR 1

50 mg shorter release CR once daily for one day

DRUG

CR 2

50 mg medium release CR once daily for one day

DRUG

CR 3

longer release SR formulation once daily for one day

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT00782600 on ClinicalTrials.gov