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
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
- lead INDUSTRY
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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