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Clarithromycin

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

Clarithromycin · 3 trials · 1 indication

Phase 1 3
NCT00648830Comparative Bioavailability Study of Clarithromycin 250 mg TabletsHealthy
COMPLETED32 Analytics
NCT00648960Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting StateHealthy
COMPLETED64 Analytics
NCT00648128Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed StateHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Comparative Bioavailability Study of Clarithromycin 250 mg Tablets
Healthy
NCT0064883032
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PHASE1COMPLETED
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State
Healthy
NCT0064896064
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PHASE1COMPLETED
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State
Healthy
NCT0064812844
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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 to 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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Frequently asked questions about Clarithromycin

What is Clarithromycin used for?

Clarithromycin is a small molecule antibiotic being studied in healthy volunteers for bioavailability comparisons. It is developed by Viatris Inc. and is currently in Phase 1 clinical development. The drug is being tested in tablet formulations at 250 mg and 500 mg doses.

Who makes Clarithromycin?

Clarithromycin is developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the bioavailability of Clarithromycin tablets in healthy adult volunteers.

What phase is Clarithromycin in?

Clarithromycin is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers for bioavailability purposes. All three clinical trials for Clarithromycin have been completed, with no active trials currently ongoing.

What clinical trials is Clarithromycin in?

Clarithromycin has been studied in three completed Phase 1 clinical trials: NCT00648128, NCT00648830, and NCT00648960. These trials evaluated the comparative bioavailability of Clarithromycin 500 mg and 250 mg tablets in fed and fasting states, enrolling a total of 140 healthy volunteers in Canada.

Is Clarithromycin FDA approved?

Clarithromycin is an investigational drug currently in Phase 1 clinical development. It has not been approved by the FDA for any use. The drug is being studied in healthy volunteers for bioavailability comparisons, and all clinical trials have been completed.