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Mercaptopurine

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Mercaptopurine · 1 trial · 1 indication

Phase 1 1
NCT00648336Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mgHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMercaptopurine 50 mg
2ACTIVE_COMPARATORPurinethol® Tablets 50 mg

Interventions

NameTypeDescription
Mercaptopurine 50 mgDRUG50mg, single dose fasting
Purinethol® Tablets 50 mgDRUG50mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male 3. Volunteers are to be sterile (documentation required) or during the course of the study, from study screen until 3 months after study exit, non-sterile male volunteers must use a spermicide-containing barrier method of contraception to...

Countries:United States
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