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Clarithromycin

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 Enrollment172
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00835692Clarithromycin 500 mg Tablets Under Fasting ConditionsPHASE1 COMPLETED 60 — — Sep 1, 2002Sep 1, 2002Aug 20, 20242 United States
NCT00840411Clarithromycin 500 mg Extended Release Tablets Under Fasting ConditionsPHASE1 COMPLETED 66 — — Sep 1, 2002Oct 1, 2002Aug 19, 20241 United States
NCT00840216Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.PHASE1 COMPLETED 22 — — Aug 1, 2002Aug 1, 2002Aug 19, 20241 United States
NCT00836706Clarithromycin 500 mg Tablets Under Non-Fasting ConditionsPHASE1 COMPLETED 24 — — Jul 1, 2002Jul 1, 2002Aug 20, 20241 United States
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Study Endpoints
Primary Endpoints
Cmax - Maximum Observed Concentration
Blood samples collected over 48 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 48 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)
Blood samples collected over 48 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
Blood samples collected over 36 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Clarithromycin TabletsEXPERIMENTALClarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
Biaxin® TabletsACTIVE_COMPARATORBiaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period
Clarithromycin (test) FirstEXPERIMENTAL -
Biaxin® XL (reference) FirstACTIVE_COMPARATOR -
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Clarithromycin (test)EXPERIMENTALClarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
Biaxin®ACTIVE_COMPARATORBiaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period
Interventions
NameTypeDescription
ClarithromycinDRUG500 mg Tablet
Biaxin®DRUG500 mg Tablet
Clarithromycin ER 500 mg tabletsDRUG1 x 500 mg
BIAXIN® XL 500 mg tabletsDRUG1 x 500 mg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The subject's body mass index (BMI) should be less than or equal to 30. Each subject will complete the screening process within 28 days prior to period I dosing. Co...

Countries:United States
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