Comparison of Bioavailability of Ruxolitinib Phosphate 20 mg Tablet vs Ruxolitinib 20 mg Tablet in Healthy Volunteers

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What is this study about?

The investigation involves the drug ruxolitinib, which is taken by mouth as a 20 mg tablet. The study is performed in healthy volunteers, not in people with a specific illness, to see how the medication is absorbed when taken as two slightly different tablet versions.

The purpose of the study is to compare the bioavailability of the two tablet forms, meaning how much of the medicine reaches the bloodstream. Participants will receive one tablet type, have a short break, and then receive the other tablet type, while blood samples are collected to measure how the drug behaves in the body. The main measurements include Cmax (the highest level of the drug in the blood), AUC (the total amount of drug exposure over time), tmax (the time it takes to reach the highest level), and t1/2 (how long it takes for the drug level to drop by half). Safety is also checked by monitoring for any adverse events such as unusual symptoms or changes in vital signs and lab tests.

1 first dosing day

arrive at the clinic after an overnight fast; no food or drink (except water) for at least 10 hours before the dose.

receive a single oral tablet containing 20 mg of ruxolitinib. the tablet may be the test product (ruxolitinib phosphate) or the comparator product (jakavi 20 mg tablet) depending on random assignment.

swallow the tablet with a small amount of water and remain seated for a short observation period.

2 blood sampling after first dose

allow study staff to draw small amounts of blood at several time points over the next several hours to measure how much ruxolitinib is in the blood.

the measurements include the highest concentration (often called cmax, which means the peak level) and the overall exposure (called auc, which represents the total amount of drug that reaches the bloodstream).

continue to fast until the sampling period is finished.

3 washout period

do not take any study medication for the time instructed by the study staff, allowing the first dose of ruxolitinib to leave the body before the next dose.

maintain normal daily activities and diet unless otherwise directed.

4 second dosing day

return to the clinic after another overnight fast.

receive a single oral tablet containing 20 mg of the alternative product (if the test product was taken first, the comparator is taken now, or vice versa).

swallow the tablet with water and remain seated for a short observation period.

5 blood sampling after second dose

allow study staff to draw blood at the same series of time points as after the first dose to compare how the two products are absorbed.

the same parameters (cmax, auc, time to maximum concentration, and others) are measured to assess any differences.

6 final assessment

complete any remaining safety checks, including vital signs and basic laboratory tests, to record any side effects that may have occurred during the study.

receive information about the study completion and the next steps for data analysis.

Who Can Join the Study?

Give free written informed consent before any study procedures are done.
Show negative test results for HIV-1 and HIV-2 antibodies (tests for the virus that can cause AIDS), for Hepatitis B surface antigen (test for a liver infection called hepatitis B), and for Hepatitis C antibodies (test for a liver infection called hepatitis C).
Be a non‑smoker or have not used any tobacco or nicotine products for at least 3 months before the screening visit.
If you are female, you must either be unable to become pregnant (non‑childbearing potential) or, if you could become pregnant, you must agree to use an approved contraceptive method (birth control) from at least 4 weeks before the first dose until at least 4 weeks after the last dose.
Be willing to follow all study procedures and any restrictions that are asked of you.
Be between 18 and 55 years old (inclusive) when you sign the consent form.
Have a body mass index (BMI) between 18.5 and 30.0 kg/m², which is a measure of weight relative to height.
Have no important diseases noted in your medical history.
Have no important problems found during a physical examination.
Have normal vital signs such as blood pressure and heart rate.
Have a normal 12‑lead ECG (a test that records the electrical activity of the heart).
Have normal results on all required clinical laboratory tests (blood and urine tests).

Who Cannot Join the Study?

You have a known allergy or severe reaction to the study drug or any of its inactive ingredients (hypersensitivity).
You have ever had shingles (herpes zoster), a painful skin rash caused by the chicken‑pox virus.
You have a condition that makes you more likely to get infections, such as a weakened immune system (immunodepression), low white blood cells (neutropenia), a history of cancer (malignancies), or removal of the spleen (splenectomy).
You have lived in or traveled to places where tuberculosis or certain fungal infections are common within the last three months.
You have ever had any type of cancer.
Your blood pressure is high (systolic above 145 mmHg or diastolic above 95 mmHg).
Your platelet count (cells that help blood clot) is lower than normal.
Your hemoglobin level (protein that carries oxygen in the blood) is lower than normal.
Your neutrophil count (a type of white blood cell) is lower than normal.
You tested positive on an Interferon‑gamma release assay (IGRA), a test for latent tuberculosis infection.
Your liver enzymes (ALT or AST) are higher than the normal range, indicating possible liver issues.
You have a rare inherited problem that prevents your body from processing certain sugars, such as galactose intolerance, lactase deficiency, or glucose‑galactose malabsorption.
Your blood lipase level (an enzyme that helps digest fats) is higher than normal.
Your kidney function, measured by creatinine clearance using the Cockcroft‑Gault formula, is below the normal range.
You test positive for illegal drugs or alcohol in the screening tests.
You have received a long‑acting injection or implant of any medication (except birth‑control) in the past six months.
You drink more than 14 alcoholic drinks per week (men) or more than 7 per week (women) in the past six months.
You consume more than about 500 mg of caffeine‑like substances (methylxanthines) each day from coffee, tea, soda, chocolate, etc., in the past six months.
You have taken part in any other clinical trial in the past two months.
You have taken part in more than two clinical trials in the past year.
You donated a large amount of blood (450 mL or more) or had plasma removed (plasmapheresis) in the past two months.
You have difficulty fasting or follow a special diet (e.g., lactose intolerance, vegan, low‑fat, low‑sodium) that would interfere with the study meals.
You have had a severe allergic reaction to any other medication.
Your veins in both arms are not suitable for an intravenous (IV) line.
You have trouble swallowing capsules or tablets.
If you are a woman who could become pregnant, you have a positive pregnancy test.
If you are a woman, you are currently breast‑feeding.
You are taking prescription or over‑the‑counter medicines, vitamins, supplements, or herbal products (including St John’s Wort) within two weeks of the study start, unless the doctor says they are safe.
You have used drugs that strongly affect the liver enzyme CYP3A4 (such as certain antibiotics, antifungals, HIV medicines, or some heart medicines) within four weeks before the study.
You have used drugs that increase the activity of CYP3A4 (such as carbamazepine, phenobarbital, phenytoin, rifampicin) within four weeks before the study.
You have eaten or drunk pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit (fresh, canned, or frozen) in the week before screening.
You have any medical condition (like stomach, kidney, or liver disease, ulcers, inflammatory bowel disease, pancreatitis) or past surgery (such as gallbladder removal or stomach surgery) that could affect how the drug works or your safety.
You have a history of high blood pressure (arterial hypertension).
You have a history of drug or alcohol misuse.
You currently have a serious infection, even if it is localized.
You have had a serious or opportunistic infection in the past (infections that occur when the immune system is weak).
You have a pattern of frequent infections (recurrent infections).
The study doctor believes any other condition makes you unsuitable for the trial.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bzygxqeanriw Ixxpidaryqmo E Dmwowayrvazrlal Em Szrir Lhbz	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	02.01.2024

Trial locations

Investigated Drugs:

Ruxolitinib

Ruxolitinib is an oral tablet that contains a medicine which blocks certain signals in the body called JAK pathways. By doing this, it can help control abnormal blood cell production and reduce inflammation. In this study, the tablet is being tested to see how well it is absorbed into the bloodstream when taken on an empty stomach.

Jakavi is also an oral tablet that contains the same medicine as Ruxolitinib. It is used as the reference product to compare against the test tablet. The study looks at how quickly and how much of the drug from Jakavi reaches the blood under the same fasting conditions.

Trial ID:

2023-508339-29-00

Protocol code:

BLCL-RUX-PIL01

Trial Phase:

Human Pharmacology (Phase I) – Bioequivalence Study

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Comparison of Bioavailability of Ruxolitinib Phosphate 20 mg Tablet vs Ruxolitinib 20 mg Tablet in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?