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CompletedNCT00865670Updated Mar 29, 2017

To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions

A Phase 1 interventional study of Azithromycin Monohydrate 600 mg Tablets and Zithromax (azithromycin dihydrate) 600 mg Tablets 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 (formerly part of Novartis) · 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

To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.

02

Conditions studied

  • Infection

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03

In context

Infections

6,702 studies on the registry are indexed under Infections; 801 are open to participants now.

This study's enrollment of 38 is below the median of 120 across 4,205 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Sandoz is the lead sponsor of 139 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

First submitted before Sandoz left Novartis.

Browse Sandoz studies →All Novartis studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • No clinically significant abnormal finding 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 600 mg Tablets

  • Active comparator
    2

    Zithromax (azithromycin dihydrate)600mg Tablets

    Drug: Zithromax (azithromycin dihydrate) 600 mg Tablets

06

What researchers measure

Primary outcomes

  1. Bioequivalence according to US FDA guidelines

    Time frame: 32 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2003, a primary completion of Sep 2003 and a completion of Sep 2003. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2009
First posted
Mar 19, 2009
Start
Aug 2003
Primary completionActual
Sep 2003
CompletionActual
Sep 2003
Last update
Mar 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT00865670
Lead sponsor
Sandoz
First posted
Mar 19, 2009
Start date
Aug 2003
Primary completion
Sep 2003
Completion
Sep 2003
Last update
Mar 29, 2017

Study contacts

Alan S. Marion, M.D.
principal investigator · MDS Pharma Services
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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