InfectionsPhase 1NCT00875966

Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions

A Phase 1 study testing Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC and Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer in people with Infections, run by Sandoz.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Infections
What is being tested?: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC and Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Aug 2004to Oct 2004
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

No clinically significant findings on physical exam, medial history or laboratory tests on screening

Who cannot join

Positive test for HIV or hepatitis B and C
Treatment for Drug or alcohol abuse
Any other important criteria in the protocol

About this study

Official title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

Conditions: Infections
Being tested: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC, Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLCDrug
Zithromax (azithromycin for oral suspension) 200mg/5mL PfizerDrug
Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions

Study groups in NCT00875966
Study group	Role	What they receive
1	Experimental	Azithromycin for oral suspension 200mg/5mL Receives: Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
2	Active comparator	Zithromax (azithromycin for oral suspension) 200mg/5mL Receives: Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer

What is being measured

The primary outcome is the main question the study is designed to answer.

Bioequivalence based on AUC and Cmax
Measured: 37 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2004Oct 2004

First posted6 Apr 2009 (estimated)
Study startAug 2004
Primary completionOct 2004
Study completionOct 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfectionsStudies 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: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875966
Sponsor's protocol ID: AA17045
Status last verified: Apr 2009
First submitted: 3 Apr 2009
Last updated: 29 Mar 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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 Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions
ClinicalTrials.gov ID: NCT00875966
Acronym / sponsor ID: AA17045
Conditions: Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: SandozIndustry (pharma, biotech, devices)
Study start: Aug 2004
Primary completion: Oct 2004 (actual)
Study completion: Oct 2004 (actual)
First posted: 6 Apr 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.

The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

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 for Oral Suspension 200mg/5mL Eon Pharma, LLCAzithromycin for oral suspension 200mg/5mL
2	Active comparator	Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL PfizerZithromax (azithromycin for oral suspension) 200mg/5mL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

No clinically significant findings on physical exam, medial history or laboratory tests on screening

Key exclusion criteria (3 listed)

Positive test for HIV or hepatitis B and C
Treatment for Drug or alcohol abuse
Any other important criteria in the protocol

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 for Oral Suspension 200mg/5mL Eon Pharma, LLC	Drug	1
Zithromax (azithromycin for oral suspension) 200mg/5mL PfizerSubjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions	Drug	2

Primary outcome

Bioequivalence based on AUC and Cmax
Time frame: 37 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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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC and Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer in people with Infections, 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 based on AUC and Cmax (time frame: 37 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00875966.

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.