Healthy Subjects Clinical Trial
Official title:
A Randomized, Open-label, Single-dose, 3-period Crossover Study to Describe the Pharmacokinetic Parameters of BLI-489 and Piperacillin When Administered Simultaneously Compared to When Each is Administered Alone.
The purpose of this study is to evaluate how BLI-489 and piperacillin interact when given together to healthy subjects.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening. 2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg. 3. Healthy as determined by the investigator on the basis of the screening evaluations. 4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history. Exclusion Criteria: 1. Presence of history of any disorder that may prevent the successful completion of the study. 2. History of drug abuse within 1 year. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics as evaluated by drug concentrations in the blood and urine. | 10 days | No | |
Secondary | Safety as measured by the number of adverse events and serious adverse events. | 10 weeks | No |
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