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CompletedNCT00866216Updated Mar 29, 2017

Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

A Phase 1 interventional study of Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals and Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc. in Infection, sponsored by Sandoz. Completed. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-29.

Sponsored by Sandoz · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

02

Conditions studied

  • Infection
03

In context

Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV or hepatitis B or C
  • Treatment for drug or alcohol dependence
  • Female subjects who are pregnant or lactating
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    1

    Azithromycin Monohydrate 600mg Tablets

    Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals

  • Active comparator
    2

    Zithromax (Azithromycin Dihydrate) 600mg Tablets

    Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.

Interventions

  • DrugAzithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals
  • DrugZithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.
06

What researchers measure

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 32 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00866216
Lead sponsor
Sandoz
First posted
Mar 20, 2009
Start date
Aug 2003
Primary completion
Sep 2003
Completion
Sep 2003
Last update
Mar 29, 2017

Study contacts

Alan S Marion
principal investigator · MDS Pharma
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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