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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 Trials2
Total Enrollment151

FDA Designations

No designations recorded

Nitrofurantoin/Macrocrystals clinical trials

Nitrofurantoin/Macrocrystals · 2 trials · 1 indication

Phase 1 2
NCT00649285Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mgHealthy
COMPLETED71 Analytics
NCT01018342Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mgHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collection through 28 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
2ACTIVE_COMPARATORMacrobid® Capsules 100 mg

Interventions

NameTypeDescription
Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mgDRUG100mg, single dose fed
Macrobid® Capsules 100 mgDRUG100mg, 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 Monohydrate/Macrocrystals Capsules 100 mg. The drug has been studied in Phase 1 clinical trials, with two completed trials involving a total of 151 healthy participants.

Who makes Nitrofurantoin/Macrocrystals?

Nitrofurantoin/Macrocrystals is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the company responsible for the development of this drug candidate.

What phase is Nitrofurantoin/Macrocrystals in?

Nitrofurantoin/Macrocrystals is in Phase 1 clinical development. Two Phase 1 trials have 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 evaluated in two completed Phase 1 trials: NCT01018342, which enrolled 80 healthy volunteers, and NCT00649285, which enrolled 71 healthy volunteers. Both trials were conducted in the United States and were active-controlled, randomized studies.