In short
Nitrofurantoin monohydrate is an antibiotic used to treat urinary tract infections. One completed Phase 1 clinical trial in 32 healthy subjects compared a 100 mg prolonged-release capsule formulation against the reference product Furabid®. The study measured how much of the drug reaches the bloodstream and how quickly it is absorbed.
Key points
- Nitrofurantoin monohydrate is an antibiotic classified under ATC code J01XE01.
- One Phase 1 bioequivalence trial has been completed in 32 healthy subjects.
- The trial compared a 100 mg prolonged-release capsule against the reference product Furabid®.
- The main measurements were Cmax, AUCtotal, and AUClast — how much and how fast the drug is absorbed.
- The study used a replicate crossover design, meaning each participant received both formulations.
What is nitrofurantoin monohydrate?
Nitrofurantoin monohydrate is an antibiotic substance used to treat bacterial infections of the urinary tract. It is classified under the Anatomical Therapeutic Chemical (ATC) code J01XE01, which places it among antibacterial agents used for urinary infections. The substance is available as an oral solution containing 30 mg per 5 ml in the NHS prescribing records.
The therapeutic area recorded for the clinical trials of this substance covers male urogenital diseases, bacterial infections and mycoses, and female urogenital diseases and pregnancy complications.
How does nitrofurantoin monohydrate work?
The supplementary sources provided do not describe the molecular mechanism of action of nitrofurantoin monohydrate. The substance is classified as an antibacterial agent for urinary use based on its ATC code J01XE01.
Which conditions is nitrofurantoin monohydrate used or studied for?
- Urinary tract infections — nitrofurantoin is an antibiotic used to treat bacterial infections of the urinary system.
- Healthy subjects — the registered clinical trial investigated the drug in healthy volunteers to compare how two formulations are absorbed, rather than to test treatment of a disease.
How is nitrofurantoin monohydrate given?
Nitrofurantoin monohydrate is available as an oral solution containing 30 mg per 5 ml, according to NHS prescribing records. In the clinical trial, the substance was given as a 100 mg prolonged-release capsule taken by mouth.
What do the clinical trials show?
One completed Phase 1 trial enrolled 32 healthy subjects to compare a 100 mg prolonged-release capsule of nitrofurantoin (the test product) against Furabid® 100 mg prolonged-release capsules (the reference product). The study used a replicate crossover design, meaning each participant received both formulations on different occasions, after a standard breakfast.
The primary measurements were pharmacokinetic parameters: Cmax (the maximum concentration of the drug in the blood), AUCtotal (the total amount of drug in the blood over time), and AUClast (the amount of drug in the blood up to the last measurable time point). These measurements show the rate and extent to which the drug is absorbed into the bloodstream.