HealthyPhase 1NCT06558045
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
A Phase 1 study testing Rivaroxaban 20 mg film-coated tablet and Xarelto 20 mg film-coated tablet in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rivaroxaban 20 mg film-coated tablet and Xarelto 20 mg film-coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Jul 2023to 2 Oct 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
- Aged 18 - 55 years inclusive.
- Non-smokers.
- Body mass index within 18 to 25 kg/m2.
- Vital signs (after 10 minutes rest) must be within the following ranges:
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- Systolic blood pressure: 100 - 129 mmHg
- Diastolic blood pressure: 60 - 84 mmHg
- Pulse rate: 60 - 90 bpm.
- Willing to practice abstention or contraception during the study.
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) values should be within normal range.
- Normal renal function with acceptable creatinine clearance (CrCl) >50 mL/min.
Who cannot join
- History of allergy or hypersensitivity or contraindication to rivaroxaban or factor Xa inhibitors or allied drugs.
- Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
- Patient with significant liver disease (severe hepatic impairment/Child Pugh C).
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
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- Positive result for COVID-19 rapid antigen test (this criteria only applied if the study conduct during pandemic condition).
- Clinically significant hematology abnormalities.
- Clinically significant electrocardiogram (ECG) abnormalities.
- Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
- Past history of anaphylaxis or angioedema.
- History of drug or alcohol abuse within 12 months prior to screening for this study.
- Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
- History of any bleeding or coagulative disorders.
- History of significant head or spinal cord injury or recent surgery on the brain, spinal cord or eyes.
- Presence of difficulty in accessibility of veins in left or right arm.
- A donation or significant blood loss within 90 days before this study's first dosing day.
- Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study's first dosing day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioequivalence Study of Rivaroxaban 20 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Xarelto® 20 mg Film-Coated Tablet, Manufactured by Bayer AG, Germany, Imported by PT Bayer Indonesia, Indonesia) When Administered Under Fed Condition in Healthy Subjects
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects.
Read the detailed description
The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects. This was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The participating subjects were given orally the test drug (rivaroxaban 20 mg film-coated tablet produced by PT Dexa Medica) or the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) with total 200 mL of water 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. Subjects had to ingest meal within 30 minutes or less.
Start and end of breakfast were documented. The subject's oral cavity was checked thoroughly to confirm complete medication and fluid consumption after dosing. Blood samples were drawn before taking the drug (control), and at 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.00, 24.00 and 36.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of rivaroxaban following single dose administration. The plasma concentrations of rivaroxaban were determined by using a validated ultra-performance liquid chromatography with tandem mass spectrometry detection (UPLC-MS/MS).
- Conditions
- Healthy
- Being tested
- Rivaroxaban 20 mg film-coated tablet, Xarelto 20 mg film-coated tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 20 mg film-coated tabletDrug
One tablet of the test drug was given orally 30 minutes after subjects have consumed a standardized high fat meal as breakfast
Xarelto 20 mg film-coated tabletDrug
One tablet of the reference drug was given orally 30 minutes after subjects have consumed a standardized high fat meal as breakfast
| Study group | Role | What they receive |
|---|---|---|
| Test Rivaroxaban 20 mg PT Dexa Medica | Experimental | Rivaroxaban 20 mg Film-coated Tablet, produced by PT Dexa Medica, Indonesia Receives: Drug: Rivaroxaban 20 mg film-coated tablet |
| Reference Xarelto 20 mg Bayer | Active comparator | Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia Receives: Drug: Xarelto 20 mg film-coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t)
Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t
Measured: 36 hours
Cmax
Maximum plasma concentration
Measured: 36 hours
Secondary outcomes (3)
AUC(0-inf)
Area under the plasma concentration-time curve extrapolated to infinitive time
Measured: 36 hours
T1/2
Plasma half-life
Measured: 36 hours
Tmax
Time taken to reach maximum observed plasma concentration
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start6 Jul 2023
- Primary completion18 Jul 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- This was a bioequivalence study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558045
- Sponsor's protocol ID
- BE. 787/EQL/2023
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Rivaroxaban 20 mg Film-Coated Tablet Produced by PT Dexa Medica in Comparison With the Comparator Drug (Xarelto® 20 mg Film-Coated Tablet, Manufactured by Bayer AG, Germany, Imported by PT Bayer Indonesia, Indonesia) When Administered Under Fed Condition in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06558045
- Acronym / sponsor ID
- BE. 787/EQL/2023
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 16 Aug 2024 (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 study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects.
Detailed description
The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) when administered under fed condition in healthy subjects. This was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The participating subjects were given orally the test drug (rivaroxaban 20 mg film-coated tablet produced by PT Dexa Medica) or the comparator drug (Xarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia) with total 200 mL of water 30 minutes after the subjects have consumed a standardized high fat meal as breakfast meal in the first day of each period. Subjects had to ingest meal within 30 minutes or less.
Start and end of breakfast were documented. The subject's oral cavity was checked thoroughly to confirm complete medication and fluid consumption after dosing. Blood samples were drawn before taking the drug (control), and at 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.00, 24.00 and 36.00 hours after drug administration. These blood samples were used to investigate the pharmacokinetic parameters of rivaroxaban following single dose administration. The plasma concentrations of rivaroxaban were determined by using a validated ultra-performance liquid chromatography with tandem mass spectrometry detection (UPLC-MS/MS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a bioequivalence study
| Arm | Type | Receives |
|---|---|---|
| Test Rivaroxaban 20 mg PT Dexa Medica | Experimental | Drug: Rivaroxaban 20 mg film-coated tabletRivaroxaban 20 mg Film-coated Tablet, produced by PT Dexa Medica, Indonesia |
| Reference Xarelto 20 mg Bayer | Active comparator | Drug: Xarelto 20 mg film-coated tabletXarelto® 20 mg Film-Coated Tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
- Aged 18 - 55 years inclusive.
- Non-smokers.
- Body mass index within 18 to 25 kg/m2.
Key exclusion criteria (18 listed)
- History of allergy or hypersensitivity or contraindication to rivaroxaban or factor Xa inhibitors or allied drugs.
- Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
- Patient with significant liver disease (severe hepatic impairment/Child Pugh C).
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 film-coated tabletOne tablet of the test drug was given orally 30 minutes after subjects have consumed a standardized high fat meal as breakfast | Drug | Test Rivaroxaban 20 mg PT Dexa Medica |
| Xarelto 20 mg film-coated tabletOne tablet of the reference drug was given orally 30 minutes after subjects have consumed a standardized high fat meal as breakfast | Drug | Reference Xarelto 20 mg Bayer |
Primary outcome
AUC(0-t)
Time frame: 36 hours
Area under the plasma concentration-time curve to the last observer quantifiable concentration at time t
Cmax
Time frame: 36 hours
Maximum plasma concentration
3 secondary outcomes
AUC(0-inf)
Time frame: 36 hours
T1/2
Time frame: 36 hours
Tmax
Time frame: 36 hours
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 16 Aug 2024.
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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 20 mg film-coated tablet and Xarelto 20 mg film-coated tablet in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
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 12 inclusion and 18 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 16 Aug 2024. 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 Indonesia. 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?
AUC(0-t) (time frame: 36 hours). The study lists 2 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 16 Aug 2024.