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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00879983
First received: April 10, 2009
Last updated: June 11, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: azithromycin (Zithromax)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUC inf (if data permit) and AUC last of azithromycin [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC 24, Cmax, Tmax, t1/2 of azithromycin [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • vital signs, 12-lead ECG, laboratory tests and adverse events. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.
Drug: azithromycin (Zithromax)
  1. a single dose of azithromycin ER 2g
  2. 3-day regimen of azithromycin tablet 500mg
Other Name: Zithromax
Group 2
Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .
Drug: azithromycin (Zithromax)
  1. 3-day regimen of azithromycin tablet 500mg
  2. a single dose of azithromycin ER 2g
Other Name: Zithromax

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879983

Locations
China
Pfizer Investigational Site
Shanghai, China, 200040
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00879983     History of Changes
Other Study ID Numbers: A0661179
Study First Received: April 10, 2009
Last Updated: June 11, 2010
Health Authority: China: SFDA (State Food and Drug Administration)

Keywords provided by Pfizer:
azithromycin, pharmacokinetics

Additional relevant MeSH terms:
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014