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Completed

NCT Number: NCT00879983

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Shanghai, 200040, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

azithromycin (Zithromax)

Drug
  • a single dose of azithromycin ER 2g
  • 3-day regimen of azithromycin tablet 500mg

Other names: Zithromax

Primary outcomes

  1. AUC inf (if data permit) and AUC last of azithromycin

    Time frame: 2 months

Secondary outcomes

  1. AUC 24, Cmax, Tmax, t1/2 of azithromycin

    Time frame: 2 months

  2. vital signs, 12-lead ECG, laboratory tests and adverse events.

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 13, 2009
Registry last updated
Jun 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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