Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers
NCT ID: NCT00782600
Last Updated: 2009-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2008-07-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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50 mg oral suspension
once daily for one day
suspension IR
50 mg IR suspension once daily for one day
50 mg CR Type 1
once daily for one day
CR 1
50 mg shorter release CR once daily for one day
50 mg CR Type 2
once daily for one day
CR 2
50 mg medium release CR once daily for one day
50 mg SR Type 3
once daily for one day
CR 3
longer release SR formulation once daily for one day
Interventions
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suspension IR
50 mg IR suspension once daily for one day
CR 1
50 mg shorter release CR once daily for one day
CR 2
50 mg medium release CR once daily for one day
CR 3
longer release SR formulation once daily for one day
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
* Any conHistory of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* condition possibly affecting drug absorption (eg, gastrectomy).
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6341011
Identifier Type: -
Identifier Source: org_study_id
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