Status:
COMPLETED
An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen...
Eligibility Criteria
Inclusion
- Healthy volunteers.
- Male.
- 18-45 years old.
- BMI 17.5-30.5 kg/m2.
Exclusion
- Alcohol, drug, smoke user.
- Sensitive to macrolide antibiotics class drug, parn or heparin-induced thrombocytopenia.
- Severe medical or psychiatric condition or laboratory abnormality.
- Blood donation.
- 12-ECG abnormal.
- Treatment with study drug; clinically significant.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00879983
Start Date
May 1 2009
End Date
July 1 2009
Last Update
June 14 2010
Active Locations (1)
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1
Pfizer Investigational Site
Shanghai, China, 200040