Recent Updates
Recently added Catalysts

Macrobid

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

Macrobid · 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
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

Frequently asked questions about Macrobid

What is Macrobid used for?

Macrobid is a small molecule drug being developed by Viatris Inc. for use in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials studying its effects in healthy individuals.

Who makes Macrobid?

Macrobid is developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical development.

What phase is Macrobid in?

Macrobid is in Phase 1 clinical development. It has completed two Phase 1 trials, and there are no active trials currently ongoing.

What clinical trials is Macrobid in?

Macrobid has two completed Phase 1 clinical trials: NCT00649285, a food study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid Capsules 100 mg, and NCT01018342, a fed study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid Capsules 100 mg. Both trials enrolled healthy volunteers in the United States.

Is Macrobid the same as nitrofurantoin?

Macrobid is a brand name for nitrofurantoin monohydrate/macrocrystals capsules. The clinical trials for Macrobid compare it to generic versions of nitrofurantoin monohydrate/macrocrystals capsules, indicating they are the same active ingredient.