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Nitrofurantoin Macrocrystals · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Nitrofurantoin Macrocrystals 100 mg Capsules |
| 2 | ACTIVE_COMPARATOR | Macrodantin® 100 mg Capsules |
| Name | Type | Description |
|---|---|---|
| Nitrofurantoin Macrocrystals 100 mg Capsules | DRUG | 100mg, single dose fed |
| Macrodantin® 100 mg Capsules | DRUG | 100mg, single dose fed |
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...
Nitrofurantoin Macrocrystals is an investigational small molecule being studied in healthy volunteers. It is a macrocrystalline form of nitrofurantoin, an antibiotic. The drug is currently in Phase 1 clinical development, with one completed trial evaluating its pharmacokinetics in healthy subjects.
Nitrofurantoin Macrocrystals is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.
Nitrofurantoin Macrocrystals is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
Nitrofurantoin Macrocrystals has one completed clinical trial, NCT00649506, titled "Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg." This Phase 1 study enrolled 28 healthy volunteers in the United States and was active-controlled.
Nitrofurantoin Macrocrystals is being studied in comparison to Macrodantin, a reference product. The clinical trial NCT00649506 evaluated Nitrofurantoin Macrocrystals 100 mg capsules against Macrodantin 100 mg, indicating they are related formulations of the same active ingredient.