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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014