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Azithromycin

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

Azithromycin · 3 trials · 1 indication

Phase 1 3
NCT00830336A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting ConditionsHealthy
COMPLETED80 Analytics
NCT00834756Azithromycin 600 Mg Tablets, FastingHealthy
COMPLETED36 Analytics
NCT00834132Azithromycin 600 Mg Tablets, FedHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
Healthy
NCT0083033680
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PHASE1COMPLETED
Azithromycin 600 Mg Tablets, Fasting
Healthy
NCT0083475636
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PHASE1COMPLETED
Azithromycin 600 Mg Tablets, Fed
Healthy
NCT0083413224
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Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration
Blood samples collected over 168 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-t

Cmax - Maximum Observed Concentration - Azithromycin in Plasma
Blood samples collected over 168 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Azithromycin in Plasma
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration (Per Participant) - Azithromycin in Plasma
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-t

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)- Azithromycin in Plasma
Blood samples collected over 168 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Azithromycin (test)EXPERIMENTALAzithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
Zithromax® (reference)ACTIVE_COMPARATORZithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
AzithromycinEXPERIMENTALAzithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
Zithromax®ACTIVE_COMPARATORZithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period

Interventions

NameTypeDescription
AzithromycinDRUGOral Suspension
Zithromax®DRUGOral Suspension
Azithromycin 600 mg TabletDRUG1 x 600mg, single-dose fasting
Zithromax® 600 mg TabletDRUG1 x 600mg, single-dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Screening Demographics: All subjects selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be between 19 and 30. * Screening Procedures: Each subject will complete the screening process w...

Countries:United States
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