Will a cheaper blood thinner work the same as xarelto?
NCT ID NCT07807488
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether a generic 2.5 mg rivaroxaban tablet is absorbed by the body the same way as the brand-name drug Xarelto. Healthy adults receive a single dose of each version, both on an empty stomach and after a meal, to compare drug levels in the blood. The study also checks safety and tolerability. If the generic matches Xarelto, it could offer a more affordable option for preventing blood clots.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivaroxaban 2.5 mg tablet (test product compared to reference product Xarelto)
- What this could lead to
- If the test tablet proves equivalent to Xarelto, it could become a lower-cost generic option for people who need blood thinners.
- What could go wrong
- This is an early-stage study in healthy volunteers, not patients. Even if the drugs match in healthy people, real-world effects and safety in patients still need confirmation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
64 people
The number who actually took part.
- Started
-
Mar 2022
- Finished
-
Apr 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy male or female participant aged 18 years or older. * Body weight at least 50 kg for males or at least 45 kg for females, with body mass index from 19.0 to 26.0 kg/m2, inclusive. * No plan for conception or gamete donation and willing to use effective contraception from screening (from 2 weeks before screening for females) until 6 months after the last dose. * Creatinine clearance greater than 80 mL/min. * Prothrombin time and activated partial thromboplastin time within the normal ranges. * Voluntarily provided written informed consent and understood the study procedures. * Able to comply with and complete the study requirements. Exclusion Criteria: * Specific allergy history, current allergic disease, allergic constitution, or known hypersensitivity to rivaroxaban, related compounds, or formulation components. * Clinically significant abnormal findings on physical examination, vital signs, electrocardiogram, or clinical laboratory testing. * Clinically significant neurologic, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic, musculoskeletal, or other disease that could affect drug absorption, distribution, metabolism, or excretion. * Active pathological bleeding, coagulation abnormality, or clinically relevant bleeding risk. * Positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, or syphilis antibody. * Hereditary lactose or galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. * Positive pregnancy test or breastfeeding. * History of drug abuse within 5 years or positive urine drug screen. * Hospitalization or surgery within 3 months before screening. * Regular alcohol intake exceeding 14 units per week within 3 months or positive breath alcohol test. * Smoking more than 5 cigarettes per day on average within 3 months. * Participation in another clinical study with study drug exposure within 3 months. * Blood donation or blood loss of at least 400 mL within 3 months, or donation of 2 therapeutic units of platelets within 1 month. * Use of prescription medication within 14 days, or nonprescription medication, herbal medicine, or health products within 7 days before dosing. * Use within 28 days before first dosing of drugs that strongly inhibit or induce P-glycoprotein or CYP3A4. * Consumption within 48 hours before dosing of grapefruit or related products, alcohol-, caffeine-, or xanthine-containing foods or beverages; strenuous exercise; or other factors potentially affecting pharmacokinetics. * Intolerance of venipuncture or history of needle or blood phobia. * Special dietary requirements or inability to comply with the standardized diet and study restrictions. * Any other condition that could prevent completion of the study or that the investigator considered unsuitable for participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
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