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
- Registration Number
- NCT00879983
- Lead Sponsor
- Pfizer
- 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 of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy volunteers.
- Male.
- 18-45 years old.
- BMI 17.5-30.5 kg/m2.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 azithromycin (Zithromax) Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet. Group 2 azithromycin (Zithromax) Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .
- Primary Outcome Measures
Name Time Method AUC inf (if data permit) and AUC last of azithromycin 2 months
- Secondary Outcome Measures
Name Time Method AUC 24, Cmax, Tmax, t1/2 of azithromycin 2 months vital signs, 12-lead ECG, laboratory tests and adverse events. 2 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Shanghai, China