Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
Verified
Porto, Portugal
Not recruiting
Bioequivalence Study of Tofacitinib 10 mg Film-Coated Tablets in Healthy Volunteers
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
The study involves healthy volunteers and evaluates two oral tablets that contain the medication Tofacitinib, one marketed as XELJANZ. The aim is to show that the test tablet and the marketed tablet deliver the drug to the body in the same way, a concept known as bioequivalence, meaning they are expected to work similarly and be equally safe.
Participants will take a single dose of one tablet while fasting, then after a short break will take the other tablet under the same conditions. Blood samples will be collected to measure how much drug appears in the bloodstream, including the highest level reached (Cmax), the overall exposure over time (AUC), the time to reach the highest level (tmax), and how quickly the drug level falls (half‑life). Throughout the study, volunteers will be observed for any side effects or abnormal lab results, and vital signs will be checked regularly.
The research process
The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Free written informed consent must be given before any study procedures; this means signing a document after understanding what will happen in the trial.
- Must be a non‑smoker or have stopped using tobacco or nicotine products for at least 3 months before the screening visit.
- Must be willing to follow all study procedures and any restrictions that are part of the trial.
- Women are eligible if they either cannot become pregnant (non‑childbearing potential) or, if they can become pregnant, they agree to use an approved contraceptive method from at least 4 weeks before the first dose until at least 4 weeks after the last dose.
- Must be between 18 and 55 years old (inclusive) at the time of signing the consent.
- Must have a body mass index (BMI) between 18.5 and 30.0 kg/m²; BMI is a calculation that compares weight to height to assess whether weight is in a healthy range.
- Must have no clinically relevant diseases noted in the medical history.
- Must have no clinically relevant abnormalities found during the physical examination.
- Must have a normal 12‑lead ECG, which is a test that records the heart’s electrical activity.
- Must have normal results on standard clinical laboratory tests (blood and urine checks).
- Must have a negative result from the IGRA test, a blood test that screens for certain tuberculosis infections.
- Must test negative for anti‑HIV antibodies, Hepatitis B surface antigen, and anti‑Hepatitis C antibodies, which are tests for HIV, Hepatitis B, and Hepatitis C infections.
Who cannot join the trial?
41 criteria
- Known allergy to the study drug or any of its inactive ingredients.
- History of frequent infections.
- Lived or traveled to areas where tuberculosis or certain fungal infections are common within the last 3 months, or have a condition that makes infections more likely.
- History of blood clots (such as deep‑vein clot, lung clot, or artery clot) or risk factors for clotting (like inherited clotting disorders or autoimmune diseases that increase clot risk).
- History of serious heart problems such as a heart attack (myocardial infarction) or stroke.
- History of any cancer (malignancy).
- Family history of sudden death before age 40.
- Resting blood pressure (systolic or diastolic) outside the normal range.
- Low hemoglobin (the protein in red blood cells that carries oxygen) below normal.
- Low neutrophil count (a type of white blood cell that fights infection) below normal.
- Low lymphocyte count (another white‑blood‑cell type) below normal.
- Known severe allergy to any other medication.
- Liver enzymes (ALT or AST) higher than normal, indicating possible liver issues.
- Kidney function (creatinine clearance) below normal, measured by a specific calculation.
- Total cholesterol higher than the normal upper limit.
- Positive IGRA test (a blood test for tuberculosis infection).
- Positive test for illegal drugs, nicotine (cotinine), or alcohol.
- Planned receipt of live or weakened vaccines during the study or within two months after it.
- Received a long‑acting injection or implant of any drug in the past 6 months.
- Drinks more than 14 alcoholic drinks per week (men) or more than 7 per week (women) in the past 6 months.
- Consumes more than about 500 mg of caffeine each day (found in coffee, tea, cola, chocolate, etc.).
- Participated in another clinical trial in the past 2 months.
- Has rare inherited problems with processing certain sugars (galactose intolerance, lactose deficiency, or glucose‑galactose malabsorption).
- Participated in more than two clinical trials in the past 12 months.
- Donated blood or lost a large amount of blood (≥ 450 mL) or had plasma exchange in the past 2 months.
- Cannot fast or follows a special diet (e.g., lactose‑free, vegan, low‑fat, low‑salt) that would interfere with the study meals.
- Veins in both arms unsuitable for drawing blood or giving an IV.
- Difficulty swallowing pills or capsules.
- If able to become pregnant, a positive pregnancy test (blood).
- If female, is currently breast‑feeding.
- Any other condition that the investigator believes makes participation unsafe.
- Recent illness, condition, or treatment that could put the person at risk or affect how the drug is processed.
- Use of prescription or over‑the‑counter medicines (including vitamins, supplements, herbs such as St John’s Wort) in the past 2 weeks unless the investigator says they are safe.
- Any gastrointestinal, kidney or liver disease or surgery (such as ulcer, inflammatory bowel disease, pancreatitis, gallbladder removal, stomach removal) that could change how the drug works or affect safety.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit, or grapefruit (fresh, canned, or frozen) in the past week.
- Use of medicines that strongly block or increase the activity of the enzyme CYP3A4 (examples include ketoconazole, itraconazole, erythromycin, clarithromycin, barbiturates, phenytoin, carbamazepine, rifampicin, etc.) in the past 4 weeks.
- History of gastrointestinal perforation or diverticulitis.
- History of diabetes mellitus.
- Active or past tuberculosis.
- Current infection, even if it is localized to one area of the body.
- History of a serious or opportunistic infection.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Tofacitinib
is an oral tablet that contains the active ingredient tofacitinib. In this study it is the test product, meaning it is a version being examined to see if it works the same way as the approved brand. Participants take the tablet by mouth after fasting, and the researchers measure how much of the drug gets into the bloodstream and how quickly it is cleared. The goal is to show that this test tablet behaves in the same way as the reference product.
XELJANZ
is the brand-name oral tablet that also contains tofacitinib. It is used in the trial as the comparator, or reference, product because it is already approved and known to be effective. Like the test tablet, it is taken by mouth under fasting conditions, and its absorption and clearance are measured. Comparing the test tablet to XELJANZ helps determine if the new version is bioequivalent, meaning it provides the same amount of medication to the body.
What is already known about the treatment
Tofacitinib
It is taken by mouth as a 10 mg film‑coated tablet. Tofacitinib is an approved medicine used for conditions such as rheumatoid arthritis and ulcerative colitis, and it is well described in medical literature. It works by blocking the JAK enzymes that send signals for inflammation, which reduces the immune response. It belongs to the class of Janus kinase (JAK) inhibitors.
XELJANZ
XELJANZ is the brand name of tofacitinib, supplied as a 10 mg film‑coated tablet taken orally. It is an approved drug for rheumatoid arthritis and other inflammatory diseases and is widely studied in clinical research. The tablet works by inhibiting JAK enzymes, which lowers the activity of inflammatory signals in the body. XELJANZ is classified as a Janus kinase (JAK) inhibitor.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504516-15-00Protocol codeBLCL-TOF-EU-01Estimated enrolment38 patientsSponsorBluepharma Industria Farmaceutica S.A.
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?