InfectionPhase 1NCT00865670
To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
A Phase 1 study testing Azithromycin Monohydrate 600 mg Tablets and Zithromax (azithromycin dihydrate) 600 mg Tablets in people with Infection, run by Sandoz.
Trial summary
To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Azithromycin Monohydrate 600 mg Tablets and Zithromax (azithromycin dihydrate) 600 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Sep 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening
Who cannot join
- Positive test results for HIV or hepatitis B or C
- Treatment for drug or alcohol dependence
- Female subjects who are pregnant or lactating
About this study
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fed Conditions
To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.
- Conditions
- Infection
- Being tested
- Azithromycin Monohydrate 600 mg Tablets, Zithromax (azithromycin dihydrate) 600 mg Tablets
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Monohydrate 600 mg TabletsDrug
Zithromax (azithromycin dihydrate) 600 mg TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Azithromycin Monohydrate 600mg Tablets Receives: Drug: Azithromycin Monohydrate 600 mg Tablets |
| 2 | Active comparator | Zithromax (azithromycin dihydrate)600mg Tablets Receives: Drug: Zithromax (azithromycin dihydrate) 600 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence according to US FDA guidelines
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startAug 2003
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan S. Marion, M.D., Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865670
- Sponsor's protocol ID
- AA03414
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600 mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600 mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00865670
- Acronym / sponsor ID
- AA03414
- Conditions
- Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Azithromycin Monohydrate 600 mg TabletsAzithromycin Monohydrate 600mg Tablets |
| 2 | Active comparator | Drug: Zithromax (azithromycin dihydrate) 600 mg TabletsZithromax (azithromycin dihydrate)600mg Tablets |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening
Key exclusion criteria (3 listed)
- Positive test results for HIV or hepatitis B or C
- Treatment for drug or alcohol dependence
- Female subjects who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin Monohydrate 600 mg Tablets | Drug | 1 |
| Zithromax (azithromycin dihydrate) 600 mg Tablets | Drug | 2 |
Primary outcome
Bioequivalence according to US FDA guidelines
Time frame: 32 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan S. Marion, M.D. principal investigator
MDS Pharma Services
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin Monohydrate 600 mg Tablets and Zithromax (azithromycin dihydrate) 600 mg Tablets in people with Infection, run by Sandoz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence according to US FDA guidelines (time frame: 32 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.