Status:
COMPLETED
Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to characterise the pharmacokinetics and dose proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses of daptomycin in heal...
Eligibility Criteria
Inclusion
- Men or women (not of childbearing potential) of Chinese ethnicity
- Weight between 55Kg to 90Kg and have a Body Mass Index (BMI) between 18 and 25 kg/m2
- Have a calculated creatinine clearance within range from 80 to 120 ml/min inclusive
Exclusion
- Unable to discontinue use of HMG-CoA reductase inhibitor therapy within 7 days prior to first dose of study drug through discharge from unit
- CPK \> 2X ULN (upper limit of normal)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00858325
Start Date
February 1 2009
End Date
March 1 2009
Last Update
January 22 2010
Active Locations (1)
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1
Research Site
Beijing, China