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Nitrofurantoin Macrocrystals

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Nitrofurantoin Macrocrystals clinical trials

Nitrofurantoin Macrocrystals · 1 trial · 1 indication

Phase 1 1
NCT00649506Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mgHealthy
COMPLETED28 Analytics
PHASE1COMPLETED
Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNitrofurantoin Macrocrystals 100 mg Capsules
2ACTIVE_COMPARATORMacrodantin® 100 mg Capsules

Interventions

NameTypeDescription
Nitrofurantoin Macrocrystals 100 mg CapsulesDRUG100mg, single dose fed
Macrodantin® 100 mg CapsulesDRUG100mg, single dose fed
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Eligibility Criteria

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

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to e...

Countries:United States
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Frequently asked questions about Nitrofurantoin Macrocrystals

What is Nitrofurantoin Macrocrystals?

Nitrofurantoin Macrocrystals is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as Nitrofurantoin Macrocrystals 100 mg Capsules. The drug has been studied in a Phase 1 clinical trial and is not approved for any indication based on the available data.

Who makes Nitrofurantoin Macrocrystals?

Nitrofurantoin Macrocrystals is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the drug's development.

What phase is Nitrofurantoin Macrocrystals in?

Nitrofurantoin Macrocrystals is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is Nitrofurantoin Macrocrystals in?

Nitrofurantoin Macrocrystals has been studied in one completed Phase 1 trial: NCT00649506, titled "Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg." The trial enrolled 28 healthy adult volunteers in the United States and was active-controlled and randomized.