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Clarithromycin

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Clarithromycin development status

FDA approval on record Mar 3, 2000
Approval holderAbbvie
ApplicationNDA050775
Highest phase Phase 4 run by Damascus Hospital (NCT02693574)
Phase scored for VTRSPhase 1
Registered trials 54 across 31 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment140

FDA Designations

No designations recorded

Clarithromycin clinical trials

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
HealthyUnlock trial analytics
PHASE1COMPLETED
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State
HealthyUnlock trial analytics
PHASE1COMPLETED
Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State
HealthyUnlock trial analytics

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?

Clarithromycin is a small molecule drug developed by Viatris Inc. (ticker VTRS). It has been studied in Phase 1 clinical trials, and the specific therapeutic indication for these studies is undisclosed. The trials to date have focused on comparative bioavailability in healthy adult volunteers.

Who makes Clarithromycin?

Clarithromycin is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor associated with the clinical development program for this small molecule asset.

What phase is Clarithromycin in?

Clarithromycin is in Phase 1 clinical development. All three of its recorded trials are Phase 1 studies, and all three have been completed. There are currently no active trials listed for this asset.

What clinical trials is Clarithromycin in?

Clarithromycin has been evaluated in three completed Phase 1 trials: NCT00648960, a bioavailability study of 500 mg tablets in the fasting state; NCT00648830, a bioavailability study of 250 mg tablets; and NCT00648128, a bioavailability study of 500 mg tablets in the fed state. All enrolled healthy volunteers in Canada.

How many patients were enrolled in Clarithromycin trials?

The three completed Phase 1 trials of Clarithromycin enrolled a total of 140 healthy volunteers. NCT00648960 enrolled 64 participants, NCT00648128 enrolled 44, and NCT00648830 enrolled 32. All trials were randomized and active controlled, and participants were 18 years or older.