BioequivalencePhase 1BioequivalenceNCT04689919
Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions
A Phase 1 study testing Rivaroxaban 20 MG Oral Tablet in people with Bioequivalence, run by University of Karachi at 1 site in Pakistan.
Trial summary
A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- 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
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Feb 2022to 5 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 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12 Lead ECG, and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis), as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (Opiates, benzodiazepines, amphetamines, barbiturates, cannabinoids and cocaine will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects and their partners are willing to use reliable non-hormonal contraceptive methods (condoms, diaphragm, non-hormonal intra-uterine device (IUD), female or male sterilization or sexual abstinence) throughout the study and up to 30 days after the last administration of the study drug.
- All subjects should be free from any epidemic or contagious diseases (e.g. Malaria, Dengue, Covid-19).
- Subjects will be able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
Who cannot join
- History of smoking (≤3cigarette/day), alcoholism, and test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, gastrointestinal (GI) bleeding within 6 months of randomization, history of intracranial, intraocular, spinal or atraumatic intra-articular bleeding, chronic hemorrhagic disorder, known intracranial neoplasm, arteriovenous malformation, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subjects receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g., ritonavir).
- Subjects receiving NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors as these medicinal products typically increase the bleeding risk.
- Subjects receiving concomitant P-gp inhibitor (Erythromycin, Clarithromycin and Azithromycin).
- The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital or St. John's Wort (Hypericum perforatum).
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- Subject with known coagulation disorders (e.g. von Willebrand's disease, hemophilia)
- Subject with known disorders with increased bleeding risk (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer).
- Subject with known sensitivity to common causes of bleeding (e.g. nasal).
- Individuals with mild (creatinine clearance 50 - 80 ml/min), moderate (creatinine clearance 30 - 49 ml/min) and severe (creatinine clearance 15 - 29 ml/min) renal impairment.
- Subject is allergic to Rivaroxaban and/or other Factor Xa inhibitors.
- Subject has received any investigational drug within four weeks.
- Subjects with significant hepatic disease (including moderate to severe hepatic impairment, i.e. Child-Pugh B and C) which is associated with coagulopathy leading to a clinically relevant bleeding risk.
- Subjects with cardiac related conditions (hemodynamically significant mitral valve stenosis, prosthetic heart valve, planned cardioversion, transient atrial fibrillation caused by reversible disease Subjects with known presence of atrial myxoma or left ventricular thrombus and active endocarditis.[8]
- Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- Ingestion of OTC drug, within 7 days of drug administration.
- History of intake of any prescribed medicine during a period of 30 days, prior to drug administration day of study.
- History of any significant illness in the last four weeks
- Consumption of grapefruit and/or its products within 14 days prior to the start of study.
- Vitamin, dietary supplements and herbal products must be discontinued 14 days prior to the first dose of study medication.
- Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- Individuals having undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he/she may designate.
- Subject has a history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Rivaroxaban to the subject.
- Inability to take oral medication.
- Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.
- Subjects testing positive for COVID-19 or are known to have such family members who tested positive for COVID-19 in recent times will also be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, 75270
About this study
Official title: A Single Center, Open Label, Randomized, Single-dose, Two Period Two Way Cross-over Study to Explore the Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions in Healthy Male Pakistani Subjects.
A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days. Blood samples will be taken up to 48hours post-dose.
Read the detailed description
Single oral administrations of study drug in two periods separated by a washout period of 07 days. Subjects will take their assigned study medication orally, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point. Total duration of treatment of study drug will be of 58 hours comprising 10 hours prior drug administration until 48 hours post dose in each study period.
Pharmacokinetic parameters include Rivaroxaban plasma concentrations at the given sampling times. In each period 16 blood samples for plasma Rivaroxaban concentrations will be taken on Day 2, Day 3 and Day 4 including 0.00 hour pre dose and post dose at 0.25, 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.5, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00 and 48.00 hours.
- Conditions
- Bioequivalence
- Being tested
- Rivaroxaban 20 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 20 MG Oral TabletDrug
The subjects randomly received single oral dose of Rivaroxaban 20 MG Tablet.
| Study group | Role | What they receive |
|---|---|---|
| Reference Group [Xarelto 20mg (Rivaroxaban) Tablet] | Active comparator | Subjects will take their assigned study medication, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point Receives: Drug: Rivaroxaban 20 MG Oral Tablet |
| Test Group [Xaroban 20mg (Rivaroxaban) Tablet] | Experimental | Subjects will take their assigned study medication, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point Receives: Drug: Rivaroxaban 20 MG Oral Tablet |
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: 2 weeks
Area under the plasma concentration versus time curve (AUC) 0-t
plasma concentration-time curve from zero to the time of the last measurable time point t
Measured: 2 weeks
Area under the plasma concentration versus time curve (AUC)0-∞
area under the plasma concentration-time curve from zero to infinity
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start19 Feb 2022
- Primary completion7 Mar 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Two period Two way cross-over study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- The Searle Company Limited Pakistan, Center for Bioequivalence Studies and Clinical Research
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
- Investigators
- Muhammad Raza Shah, PhD, Principal investigator, CBSCR , ICCBS, University of KarachiNaghma Hashmi (Co-PI), PhD, Principal investigator, CBSCR, ICCBS, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689919
- Sponsor's protocol ID
- CB-025-RIV-2018/Protocol/1.0
- Acronym
- Bioequivalence
- Status last verified
- Sep 2022
- First submitted
- 17 Dec 2020
- Last updated
- 7 Sep 2022
- 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 The Searle Co., Ltd. and the research center (CBSCR). The information can not be disclosed or distributed in any way without the written permission of the General Manager of CBSCR-ICCBS \& The Searle Company.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Randomized, Single-dose, Two Period Two Way Cross-over Study to Explore the Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions in Healthy Male Pakistani Subjects.
- ClinicalTrials.gov ID
- NCT04689919
- Acronym / sponsor ID
- Bioequivalence / CB-025-RIV-2018/Protocol/1.0
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- The Searle Company Limited Pakistan, Center for Bioequivalence Studies and Clinical Research
- Study start
- 19 Feb 2022 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 30 Dec 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.
A single center, open label, randomized, single-dose, two period, Two way cross-over study to explore the Bioequivalence of Test Product Xaroban (Rivaroxaban) 20 mg Tablet with the reference product Xarelto (Rivaroxaban) 20 mg tablet under fed conditions in healthy Pakistani male subjects. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days. Blood samples will be taken up to 48hours post-dose.
Detailed description
Single oral administrations of study drug in two periods separated by a washout period of 07 days. Subjects will take their assigned study medication orally, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point. Total duration of treatment of study drug will be of 58 hours comprising 10 hours prior drug administration until 48 hours post dose in each study period.
Pharmacokinetic parameters include Rivaroxaban plasma concentrations at the given sampling times. In each period 16 blood samples for plasma Rivaroxaban concentrations will be taken on Day 2, Day 3 and Day 4 including 0.00 hour pre dose and post dose at 0.25, 0.5, 1.00, 1.50, 2.00, 2.50, 3.00, 3.5, 4.00, 6.00, 8.00, 12.00, 24.00, 36.00 and 48.00 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two period Two way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Reference Group [Xarelto 20mg (Rivaroxaban) Tablet] | Active comparator | Drug: Rivaroxaban 20 MG Oral TabletSubjects will take their assigned study medication, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point |
| Test Group [Xaroban 20mg (Rivaroxaban) Tablet] | Experimental | Drug: Rivaroxaban 20 MG Oral TabletSubjects will take their assigned study medication, together with 240 mL of ambient temperature water, at least 1 hour after start of the meal at their scheduled dosing time-point |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate, and temperature), 12 Lead ECG, and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis), as determined by the investigator.
- Subjects should have negative urine test for drugs of abuse (Opiates, benzodiazepines, amphetamines, barbiturates, cannabinoids and cocaine will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects and their partners are willing to use reliable non-hormonal contraceptive methods (condoms, diaphragm, non-hormonal intra-uterine device (IUD), female or male sterilization or sexual abstinence) throughout the study and up to 30 days after the last administration of the study drug.
Key exclusion criteria (27 listed)
- History of smoking (≤3cigarette/day), alcoholism, and test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, gastrointestinal (GI) bleeding within 6 months of randomization, history of intracranial, intraocular, spinal or atraumatic intra-articular bleeding, chronic hemorrhagic disorder, known intracranial neoplasm, arteriovenous malformation, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subjects receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e.g., ritonavir).
- Subjects receiving NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors as these medicinal products typically increase the bleeding risk.
- Subjects receiving concomitant P-gp inhibitor (Erythromycin, Clarithromycin and Azithromycin).
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 TabletThe subjects randomly received single oral dose of Rivaroxaban 20 MG Tablet. | Drug | Reference Group [Xarelto 20mg (Rivaroxaban) Tablet], Test Group [Xaroban 20mg (Rivaroxaban) Tablet] |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 2 weeks
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 2 weeks
plasma concentration-time curve from zero to the time of the last measurable time point t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 2 weeks
area under the plasma concentration-time curve from zero to infinity
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 7 Sep 2022.
- Individual participant dataSharing planned: No. All the technical achievements and outcomes of this trial are owned by The Searle Co., Ltd. and the research center (CBSCR). The information can not be disclosed or distributed in any way without the written permission of the General Manager of CBSCR-ICCBS \& The Searle Company.
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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.
Muhammad Raza Shah, PhD principal investigator
CBSCR , ICCBS, University of Karachi
Naghma Hashmi (Co-PI), PhD principal investigator
CBSCR, ICCBS, University of Karachi
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 in people with Bioequivalence, run by University of Karachi at 1 site in Pakistan.
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 27 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 7 Sep 2022. 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 Pakistan. 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: 2 weeks). 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 7 Sep 2022.