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 of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
24
1. a single dose of azithromycin ER 2g 2. 3-day regimen of azithromycin tablet 500mg
1. 3-day regimen of azithromycin tablet 500mg 2. a single dose of azithromycin ER 2g
Pfizer Investigational Site
Shanghai, China
AUC inf (if data permit) and AUC last of azithromycin
Time frame: 2 months
AUC 24, Cmax, Tmax, t1/2 of azithromycin
Time frame: 2 months
vital signs, 12-lead ECG, laboratory tests and adverse events.
Time frame: 2 months
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