Healthy ParticipantsPhase 1NCT07807488
Bioequivalence Study of Rivaroxaban 2.5 mg Tablets Under Fasting and Fed Conditions
A Phase 1 study testing Rivaroxaban 2.5 mg Test Tablet and Rivaroxaban 2.5 mg Reference Tablet in people with Healthy Participants, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Rivaroxaban 2.5 mg Test Tablet and Rivaroxaban 2.5 mg Reference Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2022to 25 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Open-Label, Single-Dose, Four-Period, Two-Sequence, Fully Replicated Crossover Bioequivalence Study of Rivaroxaban 2.5 mg Tablets in Healthy Adult Participants Under Fasting and Fed Conditions
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.
Read the detailed description
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.
- Conditions
- Healthy Participants
- Being tested
- Rivaroxaban 2.5 mg Test Tablet, Rivaroxaban 2.5 mg Reference Tablet
- Keywords
- Rivaroxaban, Bioequivalence, Pharmacokinetics, Fasting, Fed
- Medical subject headings
- Fasting, Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 mg Test TabletDrug
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.
Rivaroxaban 2.5 mg Reference TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TRTR Sequence | Other | 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. Receives: Drug: Rivaroxaban 2.5 mg Test Tablet; Drug: Rivaroxaban 2.5 mg Reference Tablet |
| RTRT Sequence | Other | 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. Receives: Drug: Rivaroxaban 2.5 mg Test Tablet; Drug: Rivaroxaban 2.5 mg Reference Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Predose through 48 hours after each dose
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first dose through the end-of-study safety follow-up, up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start16 Mar 2022
- Primary completion15 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two independently enrolled cohorts (fasting and fed) were evaluated separately. Within each cohort, participants were randomized 1:1 to one of two fully replicated four-period sequences: TRTR or RTRT.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807488
- Sponsor's protocol ID
- QLS1002-01
- Other IDs
- CTR20220294
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Open-Label, Single-Dose, Four-Period, Two-Sequence, Fully Replicated Crossover Bioequivalence Study of Rivaroxaban 2.5 mg Tablets in Healthy Adult Participants Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT07807488
- Acronym / sponsor ID
- QLS1002-01
- Conditions
- Healthy Participants
- Keywords
- Rivaroxaban, Bioequivalence, Pharmacokinetics, Fasting, Fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two independently enrolled cohorts (fasting and fed) were evaluated separately. Within each cohort, participants were randomized 1:1 to one of two fully replicated four-period sequences: TRTR or RTRT.
| Arm | Type | Receives |
|---|---|---|
| TRTR Sequence | Other | Drug: Rivaroxaban 2.5 mg Test Tablet, Drug: Rivaroxaban 2.5 mg Reference TabletParticipants 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. |
| RTRT Sequence | Other | Drug: Rivaroxaban 2.5 mg Test Tablet, Drug: Rivaroxaban 2.5 mg Reference TabletParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban 2.5 mg Test TabletOne 2.5 mg rivaroxaban tablet manufactured by Qilu Pharmaceutical Co., Ltd. was administered orally with 240 mL of water in the assigned study periods. | Drug | RTRT Sequence, TRTR Sequence |
| Rivaroxaban 2.5 mg Reference TabletOne 2.5 mg Xarelto rivaroxaban tablet manufactured by Bayer Pharma AG was administered orally with 240 mL of water in the assigned study periods. | Drug | RTRT Sequence, TRTR Sequence |
Primary outcome
Maximum Plasma Concentration (Cmax) of Rivaroxaban
Time frame: Predose through 48 hours after each dose
The maximum observed plasma concentration of rivaroxaban after administration of the test or reference formulation, reported in ng/mL.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: Predose through 48 hours after each dose
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.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-infinity)
Time frame: Predose through 48 hours after each dose
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.
4 secondary outcomes
Time to Maximum Plasma Concentration (Tmax) of Rivaroxaban
Time frame: Predose through 48 hours after each dose
Terminal Elimination Half-Life (t1/2) of Rivaroxaban
Time frame: Predose through 48 hours after each dose
Terminal Elimination Rate Constant (Lambda z) of Rivaroxaban
Time frame: Predose through 48 hours after each dose
Number of Participants With Adverse Events
Time frame: From the first dose through the end-of-study safety follow-up, up to 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivaroxaban 2.5 mg Test Tablet and Rivaroxaban 2.5 mg Reference Tablet in people with Healthy Participants, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of Rivaroxaban (time frame: Predose through 48 hours after each dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.