NCT00644176

Brief Summary

The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar macrophages (AM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

November 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

First QC Date

March 19, 2008

Last Update Submit

June 3, 2011

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum

    predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose

  • Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples

    2, 4, 8, 12, 16, 24, 48, and 72 hours postdose

Secondary Outcomes (4)

  • 12-lead electrocardiograms (ECGs)

    Screening and 72 hours postdose

  • adverse events (AEs)

    Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose

  • safety laboratory tests

    Treatment day 0 and 72 hours postdose

  • vital signs

    Screening and Treatment day 0

Study Arms (2)

1

EXPERIMENTAL
Drug: azithromycin immediate release (Zithromax)Other: placebo

2

EXPERIMENTAL
Drug: azithromycin SROther: placebo

Interventions

azithromycin immediate release (Zithromax)DRUG

azithromycin IR 500 mg tablet by mouth for 1 dose

1
placeboOTHER

placebo

1
azithromycin SRDRUG

2.0 g by mouth in the form of liquid for 1 dose

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Pisa, 56126, Italy

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 26, 2008

Study Start

November 1, 2004

Study Completion

April 1, 2005

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

IT(1)