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

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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