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 Ch

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin

Criteria

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.