Healthy Volunteers Clinical Trial
Official title:
An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
Verified date | October 2009 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
Status | Completed |
Enrollment | 11 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - aged 18-55 and healthy Exclusion Criteria: - severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse - pregnant or wanting to become pregnant |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2 | 48 hrs | No | |
Secondary | safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing | 48 hrs | Yes |
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