A Phase 1 interventional study of Rivaroxaban 2.5 mg Test Tablet and Rivaroxaban 2.5 mg Reference Tablet in Healthy Participants, sponsored by The Affiliated Hospital of Qingdao University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by The Affiliated Hospital of Qingdao University · Phase 1, Interventional, and Other
This completed study compared how the body absorbed a single 2.5 mg dose of a test rivaroxaban tablet and the reference product (Xarelto) in healthy adults. The comparison was conducted separately under fasting and fed conditions. The study also evaluated the safety and tolerability of both products.
This was a single-center, randomized, open-label, single-dose, two-sequence, four-period, fully replicated crossover bioequivalence study. Healthy adults were enrolled independently into a fasting cohort (36 participants) or a fed cohort (28 participants). Within each cohort, participants were randomized 1:1 to the TRTR or RTRT treatment sequence. In each period, participants received one 2.5 mg rivaroxaban tablet with 240 mL of water; consecutive doses were separated by a washout interval of at least 7 days. Blood samples for pharmacokinetic assessment were collected before dosing and through 48 hours after dosing. Bioequivalence of the test and reference formulations was evaluated separately within the fasting and fed cohorts using Cmax, AUC0-t, and AUC0-infinity. The fasting and fed cohorts were not formally compared as a food-effect analysis.
Exclusion Criteria:
Participants received the test formulation in Periods 1 and 3 and the reference formulation in Periods 2 and 4. The same sequence was used within both the fasting and fed cohorts.
Drug: Rivaroxaban 2.5 mg Test Tablet · Drug: Rivaroxaban 2.5 mg Reference Tablet
Participants received the reference formulation in Periods 1 and 3 and the test formulation in Periods 2 and 4. The same sequence was used within both the fasting and fed cohorts.
Drug: Rivaroxaban 2.5 mg Test Tablet · Drug: Rivaroxaban 2.5 mg Reference Tablet
One 2.5 mg rivaroxaban tablet manufactured by Qilu Pharmaceutical Co., Ltd. was administered orally with 240 mL of water in the assigned study periods.
One 2.5 mg Xarelto rivaroxaban tablet manufactured by Bayer Pharma AG was administered orally with 240 mL of water in the assigned study periods.
Maximum Plasma Concentration (Cmax) of Rivaroxaban
The maximum observed plasma concentration of rivaroxaban after administration of the test or reference formulation, reported in ng/mL.
Time frame: Predose through 48 hours after each dose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Area under the rivaroxaban plasma concentration-time curve from time zero to the last quantifiable concentration, calculated after administration of the test or reference formulation and reported in h\*ng/mL.
Time frame: Predose through 48 hours after each dose
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-infinity)
Area under the rivaroxaban plasma concentration-time curve from time zero extrapolated to infinity, calculated after administration of the test or reference formulation and reported in h\*ng/mL.
Time frame: Predose through 48 hours after each dose
Time to Maximum Plasma Concentration (Tmax) of Rivaroxaban
Time from dosing to the maximum observed plasma concentration of rivaroxaban after administration of the test or reference formulation, reported in hours.
Time frame: Predose through 48 hours after each dose
Terminal Elimination Half-Life (t1/2) of Rivaroxaban
Terminal elimination half-life of rivaroxaban after administration of the test or reference formulation, reported in hours.
Time frame: Predose through 48 hours after each dose
Terminal Elimination Rate Constant (Lambda z) of Rivaroxaban
Terminal elimination rate constant of rivaroxaban estimated from the terminal phase of the log-linear plasma concentration-time curve, reported as 1/hour.
Time frame: Predose through 48 hours after each dose
Number of Participants With Adverse Events
Safety was assessed using adverse events, serious adverse events, adverse drug reactions, vital signs, physical examinations, clinical laboratory tests, coagulation tests, and 12-lead electrocardiograms.
Time frame: From the first dose through the end-of-study safety follow-up, up to 40 days
Plan to share: Undecided
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The Affiliated Hospital of Qingdao University