Recent Updates
Recently added Catalysts

Nitrofurantoin/Macrocrystals

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment151

FDA Designations

No designations recorded

Clinical trial landscape

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
Healthy
NCT0064928571
Unlock trial analytics
PHASE1COMPLETED
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
Healthy
NCT0101834280
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria