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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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Shanghai, , 200040 China
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy volunteers.

- Male.

- 18-45 years old.

- BMI 17.5-30.5 kg/m2.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00879983
Pfizer
Completed
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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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteers
  • Drug: azithromycin (Zithromax)
    1. a single dose of azithromycin ER 2g
    2. 3-day regimen of azithromycin tablet 500mg
    Other Name: Zithromax
  • Drug: azithromycin (Zithromax)
    1. 3-day regimen of azithromycin tablet 500mg
    2. a single dose of azithromycin ER 2g
    Other Name: Zithromax
  • Group 1
    Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.
    Intervention: Drug: azithromycin (Zithromax)
  • Group 2
    Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .
    Intervention: Drug: azithromycin (Zithromax)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
July 2009
July 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00879983
A0661179
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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