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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00879983
Enrollment
24
Registered
2009-04-13
Start date
2009-05-31
Completion date
2009-07-31
Last updated
2010-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

azithromycin, pharmacokinetics

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.

Interventions

DRUGazithromycin (Zithromax)

1. a single dose of azithromycin ER 2g 2. 3-day regimen of azithromycin tablet 500mg

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
AUC inf (if data permit) and AUC last of azithromycin2 months

Secondary

MeasureTime frame
AUC 24, Cmax, Tmax, t1/2 of azithromycin2 months
vital signs, 12-lead ECG, laboratory tests and adverse events.2 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026