NCT00879983

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 14, 2010

Status Verified

June 1, 2010

Enrollment Period

2 months

First QC Date

April 10, 2009

Last Update Submit

June 11, 2010

Conditions

Healthy Volunteers

Keywords

azithromycin, pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • AUC inf (if data permit) and AUC last of azithromycin

    2 months

Secondary Outcomes (2)

  • AUC 24, Cmax, Tmax, t1/2 of azithromycin

    2 months

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

    2 months

Study Arms (2)

Group 1

OTHER

Will accept azithromycin ER first, after at least 14 days washout, then accept azithromycin tablet.

Drug: azithromycin (Zithromax)

Group 2

OTHER

Will accept azithromycin tablet first, after at least 14 days washout, then accept azithromycin ER .

Drug: azithromycin (Zithromax)

Interventions

azithromycin (Zithromax)DRUG

1. a single dose of azithromycin ER 2g 2. 3-day regimen of azithromycin tablet 500mg

Also known as: Zithromax
Group 1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers.
  • Male.
  • years old.
  • BMI 17.5-30.5 kg/m2.

You may not qualify if:

  • 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.
  • ECG abnormal.
  • Treatment with study drug; clinically significant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Shanghai, 200040, China

Location

Related Links

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 14, 2010

Record last verified: 2010-06

Locations

CN(1)