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A RANDOMIZED, OPEN LABEL, TRIAL OF THE PHARMACOKINETICS OF AZITHROMYCIN IN SERUM, BRONCHIAL WASHINGS AND LUNG TISSUE FOLLOWING A SINGLE DOSE OF NEW FORMULATION AZITHROMYCIN MICROSPHERES (2 GRAM) OR COMMERCIAL AZITHROMYCIN TABLET (500 MG) TO CANCER PATIENTS THAT REQUIRE LUNG RESECTION.

A RANDOMIZED, OPEN LABEL, TRIAL OF THE PHARMACOKINETICS OF AZITHROMYCIN IN SERUM, BRONCHIAL WASHINGS AND LUNG TISSUE FOLLOWING A SINGLE DOSE OF NEW FORMULATION AZITHROMYCIN MICROSPHERES (2 GRAM) OR COMMERCIAL AZITHROMYCIN TABLET (500 MG) TO CANCER PATIENTS THAT REQUIRE LUNG RESECTION.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001497-13-IT
Enrollment
Unknown
Registered
2005-09-21
Start date
2004-10-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable: Pharmacokinetic study. MedDRA version: 6.1 Level: HLT Classification code 10024973

Interventions

Product Name: Azithromycin SR Product Code: CP-62,933 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: Azithromycin Concentration unit: g gram(s) Concentration type: equal Concentr

Sponsors

PFIZER
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026