Fed‑State Bioequivalence Study of Nitrofurantoin 100 mg Prolonged‑Release Capsules in Healthy Volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The medication being studied is nitrofurantoin, an antibiotic commonly used to treat urinary tract infections. In this trial two versions of the drug are compared: a test product from Iasis Pharma and the reference product called Furabid. Both are taken as prolonged-release capsules that contain 100 mg of the antibiotic, meaning the medicine is released slowly over time after swallowing.
The purpose of the study is to compare how quickly and how much of the drug is absorbed into the body when the two capsules are taken. Healthy volunteers will receive a single dose of one capsule after a standard breakfast, and blood samples will be collected over several hours to track the drug’s presence. After a short break, the same participants will take the other capsule and undergo the same sampling, while safety checks are performed throughout.
Key concepts include bioequivalence, which means the two products deliver the same amount of drug to the bloodstream; Cmax, the highest concentration reached; AUCtotal and AUClast, measurements of overall drug exposure over time; Tmax, the time it takes to reach the peak level; and half-life, the period needed for the drug amount to decrease by half. The study also monitors any adverse events, which are any unwanted side effects that may occur.
The research process
The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
14 criteria
- You must sign a written informed consent form before any other screening steps; this means you agree in writing after understanding the study.
- You must be of Caucasian race, male or female; Caucasian refers to a specific ethnic background.
- Your age must be between 18 and 55 years.
- Your Body Mass Index (BMI) must be between 18.5 and 30 kg/m²; BMI is a measure of weight relative to height.
- You must be a non‑smoker or light smoker (no more than 10 cigarettes per day); light smoker means you smoke less than 10 cigarettes daily.
- You need a normal physical exam with no important health problems found; a physical exam checks your overall health.
- Your blood pressure and heart rate must be within normal ranges: systolic 100‑140 mmHg, diastolic 60‑90 mmHg, heart rate 50‑90 beats per minute, measured while lying down after five minutes of rest; blood pressure numbers show the force of blood in your arteries, and heart rate is how many times your heart beats each minute.
- Your 12‑lead ECG (a heart rhythm test) must show normal or not significant findings.
- Your blood and urine test results (hematology, clinical chemistry, urinalysis) must be normal or not clinically significant; these tests check blood cells, chemicals in your blood, and substances in your urine.
- Female participants must have a negative serum beta‑HCG test, which shows you are not pregnant.
- You must be able to understand the study’s purpose, possible risks, and side effects.
- You must be able to swallow the study medication.
- You must be willing to work with the study doctor and follow all study rules.
- You must have health insurance, social security, or be a beneficiary.
Who cannot join the trial?
28 criteria
- History of hypersensitivity (allergic reaction) to nitrofurantoin or any ingredient in the study drug.
- History of severe allergic reactions such as anaphylaxis (a life‑threatening allergy), breathing problems like bronchospasm or asthma, or serious skin reactions (including DRESS syndrome, Stevens‑Johnson syndrome, or Lyell syndrome).
- Any food allergy, intolerance to galactose (a type of sugar), or any diet restriction that would prevent eating the study meal.
- Current or recent (within 3 months) stomach or intestinal disease (e.g., chronic diarrhea, ulcerative colitis, Crohn’s disease) or ongoing symptoms such as vomiting or diarrhea; also liver or kidney disease or any condition that could affect how the drug is absorbed, processed, or removed.
- Known deficiency of the enzyme G6PD (glucose‑6‑phosphate dehydrogenase) or a history of acute porphyria (a disorder affecting blood‑forming chemicals).
- Fever or a feverish illness within 4 days before the first dose.
- Positive test for HIV, active or chronic hepatitis B, or current hepatitis C infection (except if hepatitis C was cured and documented at least 12 weeks after treatment).
- Major gastrointestinal surgery (except a simple appendectomy).
- Any significant medical condition affecting the heart, lungs, blood, metabolism, hormones, immune system, nerves, or mental health that could make taking the drug unsafe or affect study results.
- Blood test results showing liver enzymes (AST, ALT, or alkaline phosphatase) more than 2.5 times the upper normal limit.
- Blood test showing total bilirubin more than 2.5 times the upper normal limit.
- Use of any over‑the‑counter medicines, vitamins, herbal supplements, or prescription drugs (except topical creams that do not enter the bloodstream) within the last 14 days or five drug half‑lives before the first dose.
- Use of any medication within the last 30 days that is known to speed up or slow down the body’s drug‑metabolizing enzymes.
- Receiving any vaccine within two weeks before screening.
- Receiving a long‑acting (depot) injection or implant of any drug within the last three months.
- Alcohol misuse, a history of alcoholism, or being a recovered alcoholic.
- Drinking more than five cups of coffee or similar caffeinated beverages per day.
- Inability or unwillingness to eat the study’s high‑fat breakfast (for example, vegetarian, vegan, or other special diets).
- Regular smokers who smoke more than 10 cigarettes a day or cannot refrain from smoking during the study periods.
- History of drug abuse or a positive drug‑screen test for substances such as amphetamines, barbiturates, benzodiazepines, cannabinoids, or cocaine.
- Participation in another clinical trial within the last six weeks.
- Donation of more than 450 ml of blood within the last two months.
- Lack of suitable veins for repeated blood draws.
- Unwilling or unable to follow study procedures, or unable to give written informed consent.
- Being institutionalized (living in a prison, nursing home, or similar facility).
- Female‑only: Use of oral contraceptive pills (birth‑control pills).
- Female‑only: Positive pregnancy test.
- Female‑only: Breastfeeding.
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Investigated drugs
This is a prolonged‑release capsule that contains the antibiotic nitrofurantoin. In the study it is the new product being tested to see if it works the same way as the existing medicine. Participants take a single 100 mg dose after a regular breakfast, and researchers measure how quickly and how much of the drug gets into the bloodstream. Nitrofurantoin (Furabid) – Reference Drug
Furabid is an established brand of prolonged‑release nitrofurantoin capsules. It is used as the standard comparison (the “reference”) in the trial. After a single 100 mg dose taken with a standard breakfast, the study compares its absorption profile to that of the test product to determine if the new capsule is bioequivalent.
What is already known about the treatment
Furabid
This medication is taken by mouth as a hard, modified‑release capsule that contains 100 mg of nitrofurantoin. It is an established antibiotic that has been used for many years and is well described in medical literature. The drug is mainly prescribed to treat uncomplicated urinary tract infections in both men and women. It works by entering the bacteria that cause the infection and disrupting their ability to make proteins, which kills the germs; it belongs to the nitrofuran class of antibacterial agents.
Nitrofurantoin
This product is also taken orally as a hard, prolonged‑release capsule delivering 100 mg of nitrofurantoin. It is a widely approved and commonly prescribed antibiotic with extensive documentation in clinical references. The capsule is used primarily for the treatment and prevention of urinary tract infections. Like Furabid, it attacks bacteria by interfering with their protein synthesis, leading to bacterial death, and it is classified as a nitrofuran antibacterial.
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
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