Healthy SubjectsPhase 1NCT04424381
Pharmacokinetics and Bioequivalence of Rivaroxaban Tablet in Healthy Chinese Volunteers
A Phase 1 study testing Rivaroxaban 20 MG Oral Tablet [Xarelto] and Rivaroxaban 20 MG Oral Tablet in people with Healthy Subjects, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Rivaroxaban 20 MG Oral Tablet [Xarelto] and Rivaroxaban 20 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2019to 20 Sep 2019
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female aged 18 and above.
- The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
- The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
- The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Who cannot join
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions
The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.
Read the detailed description
Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2 = RTRT, and each study period was separated by a 7 days washout period. After an overnight fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0, 2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C for 10 min.
- Conditions
- Healthy Subjects
- Being tested
- Rivaroxaban 20 MG Oral Tablet [Xarelto], Rivaroxaban 20 MG Oral Tablet
- Keywords
- rivaroxaban, pharmacokinetics, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 20 MG Oral Tablet [Xarelto]Drug
The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].
Rivaroxaban 20 MG Oral TabletDrug
The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban 20 MG Oral Tablet [Xarelto] | Active comparator | rivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg Receives: Drug: Rivaroxaban 20 MG Oral Tablet |
| Rivaroxaban 20 MG Oral Tablet | Experimental | rivaroxaban oral tablet at a single oral dose of 20 mg Receives: Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 94 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Measured: 94 days
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Measured: 94 days
Secondary outcomes (5)
Incidence of Treatment-Emergent Adverse Events
Collection of adverse events
Measured: 94 days
Incidence of abnormal blood pressure
Monitor the blood pressure
Measured: 94 days
Incidence of abnormal temperature
Monitor the temperature
Measured: 94 days
Incidence of abnormal pulse
Monitor the pulse
Measured: 94 days
Incidence of abnormal electrocardiogram waveform
Electrocardiogram inspection
Measured: 94 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start4 Jun 2019
- Primary completion5 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study was designed as a four-period complete and replicate crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yu Cao, Principal investigator, the study director of phase I clinical research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424381
- Sponsor's protocol ID
- QL-YK4-012-001
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions
- ClinicalTrials.gov ID
- NCT04424381
- Acronym / sponsor ID
- QL-YK4-012-001
- Conditions
- Healthy Subjects
- Keywords
- rivaroxaban, pharmacokinetics, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 11 Jun 2020 (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.
The study was designed as a single-site, randomized, open-label, four-period complete and replicate crossover. A single oral dose of 20 mg rivaroxaban tablet (test) and Xarelto®(reference) was given to the 72 healthy Chinese adult volunteers, with 36 in a fasting state and 36 receiving a high-fat diet.
Detailed description
Subjects were randomized into two treatment sequence groups: Sequence 1 = TRTR and Sequence 2 = RTRT, and each study period was separated by a 7 days washout period. After an overnight fast for at least 10 h, the subjects received a single oral dose of the R or T formulation of rivaroxaban tablets (20 mg) with 240 mL of water in a seated position. A total of 19 blood samples were collected at 0 (within 60 min prior to dosing) and 0.25,0.5, 1.0, 1.5, 2.0, 2.5,3.0,3.5, 4.0, 4.5,5.0, 5.5,6.0, 8.0, 12.0, 24.0, 36.0 ,and 48.0 hours after dosing.Blood samples were collected in a vacuum blood tube containing sodium heparin, gently mixed, and stored on ice-water mixture until sample processing and then centrifuged at 2000g at 2-8°C for 10 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was designed as a four-period complete and replicate crossover
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban 20 MG Oral Tablet [Xarelto] | Active comparator | Drug: Rivaroxaban 20 MG Oral Tabletrivaroxaban oral tablet [Xarelto] at a single oral dose of 20 mg |
| Rivaroxaban 20 MG Oral Tablet | Experimental | Drug: Rivaroxaban 20 MG Oral Tablet [Xarelto]rivaroxaban oral tablet at a single oral dose of 20 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female aged 18 and above.
- The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
- The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
- The subjects have no family planning within 3 months and could select contraceptive method.Before the study, all subjects
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Key exclusion criteria (2 listed)
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
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 20 MG Oral Tablet [Xarelto]The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto]. | Drug | Rivaroxaban 20 MG Oral Tablet |
| Rivaroxaban 20 MG Oral TabletThe subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet. | Drug | Rivaroxaban 20 MG Oral Tablet [Xarelto] |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 94 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 94 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 94 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 94 days
Incidence of abnormal blood pressure
Time frame: 94 days
Incidence of abnormal temperature
Time frame: 94 days
Incidence of abnormal pulse
Time frame: 94 days
Incidence of abnormal electrocardiogram waveform
Time frame: 94 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 11 Jun 2020.
- Individual participant dataSharing planned: No. All the technical achievements and outcomes of this trial are owned by Qilu Pharmaceutical Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor
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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.
yu Cao principal investigator
the study director of phase I clinical research center
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 20 MG Oral Tablet [Xarelto] and Rivaroxaban 20 MG Oral Tablet in people with Healthy Subjects, 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 5 inclusion and 2 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 11 Jun 2020. 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?
Peak Plasma Concentration (Cmax) (time frame: 94 days). 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 11 Jun 2020.