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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: azithromycin (Zithromax)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00879983

A0661179

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

24 participants in 2 patient groups

Group 1

Other group

Description:

Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.

Treatment:

Drug: azithromycin (Zithromax)

Group 2

Other group

Description:

Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .

Treatment:

Drug: azithromycin (Zithromax)