Recent Updates
Recently added Catalysts

Zithromax

Phase 1

Infection | Small molecule | Infectious Disease |Novartis AG|Last Updated: Mar 29, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

Zithromax · 1 trial · 1 indication

Phase 1 1
NCT00865670To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed ConditionsInfection
COMPLETED38 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence according to US FDA guidelines
32 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAzithromycin Monohydrate 600mg Tablets
2ACTIVE_COMPARATORZithromax (azithromycin dihydrate)600mg Tablets

Interventions

NameTypeDescription
Azithromycin Monohydrate 600 mg TabletsDRUG -
Zithromax (azithromycin dihydrate) 600 mg TabletsDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening Exclusion Criteria: * Positive test results for HIV or hepatitis B or C * Treatment for drug or alcohol dependence * Female subjects who are pregnant or ...

Unlock Eligibility Criteria

Frequently asked questions about Zithromax

What is Zithromax used for?

Zithromax is a small molecule drug being developed for the treatment of Infection. It is currently in Phase 1 clinical development. The drug is being studied for its bioavailability under fed conditions, as part of its development for infectious disease indications.

Who makes Zithromax?

Zithromax is being developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's properties for the treatment of Infection.

What phase is Zithromax in?

Zithromax is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently ongoing.

What clinical trials is Zithromax in?

Zithromax has one completed clinical trial, identified as NCT00865670. This Phase 1 study, titled 'To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions,' enrolled 38 participants and was an active-controlled, randomized trial.

Is Zithromax the same as azithromycin?

Zithromax is the brand name for azithromycin, a macrolide antibiotic. The clinical trial for Zithromax specifically evaluates azithromycin 600 mg tablets, indicating that Zithromax and azithromycin refer to the same active pharmaceutical ingredient.