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Zithromax

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials4
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00830206A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Fasting ConditionsPHASE1 COMPLETED 80 — — Jan 1, 2006Jan 1, 2006Aug 20, 20241 United States
NCT00830336A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting ConditionsPHASE1 COMPLETED 80 — — Oct 1, 2005Nov 1, 2005Aug 20, 20241 United States
NCT00834756Azithromycin 600 Mg Tablets, FastingPHASE1 COMPLETED 36 — — Sep 1, 2002Oct 1, 2002Aug 19, 20241 United States
NCT00834132Azithromycin 600 Mg Tablets, FedPHASE1 COMPLETED 24 — — Jul 1, 2002Aug 1, 2002Aug 19, 20241 United States
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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 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® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin 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
AzithromycinOTHEROral 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 — 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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