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Clarithromycin

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 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_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648830Comparative Bioavailability Study of Clarithromycin 250 mg TabletsPHASE1 COMPLETED 32May 1, 2004Jun 1, 2004Apr 24, 20241 Canada
NCT00648960Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting StatePHASE1 COMPLETED 64Jul 1, 2003Jul 1, 2003Apr 1, 20081 Canada
NCT00648128Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed StatePHASE1 COMPLETED 44Mar 1, 2003Mar 1, 2003Apr 1, 20081 Canada
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameters (AUC & Cmax)
within 14 days
Pharmacokinetic; The 90% confidence interval for the exponential of the difference between the Test and the Reference product for the ln-transformed parameters Cmax, AUCT and AUC∞ should be between 80 and 125%.
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALClarithromycin 250 mg immediate-release oral tablet
2ACTIVE_COMPARATORBiaxin® (Clarithromycin) 250 mg tablet
Interventions
NameTypeDescription
ClarithromycinPROCEDURESingle-dose of Clarithromycin 250 mg oral immediate-release tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects meeting all of the following criteria may be included in the study: Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly signed by the volunteer Males or females a...

Countries:Canada
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