Rivaroxaban disposition in healthy human volunteers (obese vs non-obese population) Not Applicable
Conditions
Interventions
A single dose of rivaroxaban (20 mg film-coated tablet) is given orally to the healthy participants in both groups (obese participants with BMI =35 kg/m² or weight more than 120 kg
the control group who are normal weight participants with BMI 18.5 to ?25 kg/m²) under fed conditions. Nine blood samples are taken from all participants at the following timepoints: 0, 1, 2, 4, 8, 12
study duration is 48 h. Analysis for all samples is carried out using ultra-performance liquid chromatography to obtain rivaroxaban concentrations (and other pharmacokinetic parameters) in these sampl
Sponsors
Qatar University
International Center for Bioavailability, Pharmaceutical, and Clinical Research
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy participants from the Egyptian general population 2. Age 18-60 years 3. Body mass index 18.5 – 24.9 kg/m² for normal-weight participants OR BMI = 35 kg/m² for obese participants 4. The participant is fully aware of the study details and gave written informed consent 5. The physical examination is assessed and accepted by the attending physician 6. Oral body temperature within the normal range (35.9 – 37.6°C) 7. All laboratory screening results within the normal range for normal-weight volunteers and with some variation from the normal range for the obese participants 8. Normal coagulation tests at baseline of the study, i.e., international normalised ratio (INR) up to 1.1, prothrombin time (PT) 10 – 13 seconds, and activated partial thromboplastin time (aPTT) 30 – 40 seconds
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 18/10/2024: 1. History of hypersensitivity to the drug or similar compound 2. Having any known coagulation conditions (i.e., von Willebrand disease, haemophilia) 3. Having any known increased bleeding risk (i.e., haemorrhoids, peptic ulcer, or frequent nasal bleeding) 4. Having any chronic disease/condition (such as diabetes type 2, cardiovascular disease, hypertension, and cancer) 5. Known history or presence of food allergies or intolerability (e.g dairy product or gluten-containing food) or any condition is known to interfere with the absorption, distribution, metabolism or excretion of drugs 6. Vegetarian 7. Exhausting physical exercise in the last 24 hours (e.g. weight lifting). 8. History of serious illness that can impact the fate of drugs or clinically significant illness 3 weeks before the study 9. Obvious signs of serious renal, gastrointestinal, cardiovascular, hepatic, neurological, musculoskeletal, endocrine disorders as evidenced by physical examination, and/or clinical laboratory tests 10. Participant HB Previous participant exclusion criteria: 1. History of hypersensitivity to the drug or similar compound 2. Having any known coagulation conditions (i.e., von Willebrand disease, haemophilia) 3. Having any known increased bleeding risk (i.e., haemorrhoids, peptic ulcer, or frequent nasal bleeding) 4. Having any chronic disease/condition (such as diabetes type 2, cardiovascular disease, hypertension, and cancer) 5. Known history or presence of food allergies or intolerability (e.g dairy product or gluten-containing food) or any condition is known to interfere with the absorption, distribution, metabolism or excretion of drugs 6. Vegetarian 7. Exhausting physical exercise in the last 24 hours (e.g. weight lifting). 8. History of serious illness that can impact the fate of drugs or clinically significant illness 3 weeks before the study 9. Obvious signs of serious renal, gastrointestinal, cardiovascular, hepatic, neurological, musculoskeletal, endocrine disorders as evidenced by physical examination, and/or clinical laboratory tests 10. Participant HBsAg, HCV, and HIV positive 11. History of drug or alcohol abuse, smoking more than 10 cigarettes or equivalent per day 12. Regular use of medication 13. Use of any known enzyme inducers or inhibitors (e.g. barbiturates, rivaroxaban, phenytoin, rifampin) within 30 days prior to study entry. 14. Use of any prescription or non-prescription (OTC) medication within 3 weeks prior to the study 15. Donation of at least 400 ml of blood within 60 days, or more than 150 ml of blood within 30 days, or more than 100 ml blood plasma or platelets within 14 days before the study 16. Participation in another study within 60 days prior to the start of this study 17. Body mass index less than 18.5 kg/m² 18. Hemoglobin Hb less than 13 g/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rivaroxaban concentration in blood samples is measured using ultra-performance liquid chromatography - tandem mass spectrometer (UPLC MS/MS) at baseline, 1, 2, 4, 8, 12, 18, 36 and 48 hours 2. Rivaroxaban concentration in urine samples is measured using ultra-performance liquid chromatography - tandem mass spectrometer (UPLC MS/MS) at (-2 to 0), (0 to 3), (3 to 6), (6 to 9), (9 to 12), (12 to 15), (15 to 18), at 36, and at 48 hours 3. Area under the concentration-time curve (AUC), time for maximum concentration (Tmax), volume of distribution (Vd), clearance (Cl), and half-life (t1/2) are obtained using WinNonlin software (pharmacokinetic software) at baseline, 1, 2, 4, 8, 12, 18, 36 and 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prothrombin time (PT) is measured using the standard quantitative method used in the medical laboratories at 0, 1, 2, 4, 8, 12, 18, 36, and 48 hours 2. Activated partial thromboplastin time (APTT) is measured using the standard quantitative method used in the medical care laboratories at 0, 1, 2, 4, 8, 12, 18, 36, and 48 hours | — |
Countries
Egypt
Contacts
Public ContactMajdoleen Alalawneh
Outcome results
None listed