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.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's enrollment of 64 is above the median of 45 across 311 interventional studies indexed under Fasting.
Browse Fasting studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Apr 2022, 0 months.
Of 18 phase 1 interventional studies under Fasting, half reached primary completion within 1 month of starting (the median), counting those still running; a quarter within 0 and three quarters within 3. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rivaroxaban
The Affiliated Hospital of Qingdao University →