A Bioequivalence Study of Two Formulations of Rivaroxaban 10-mg Tablets in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Healthy volunteersRivaroxabanBioequivalence studyPharmacokinetics
- Registration Number
- TCTR20220720009
- Lead Sponsor
- Sun Pharmaceutical Industries Limited, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
.Thai Male/Female must be 18-55 years of age, body weight >50.0 kg with body mass index (BMI) = 18.0-30.0 kg/m2, inclusive.
2.Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 90 or not over 129 mmHg, diastolic blood pressure not lower than 60 or not over 79 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians
3.Screening electrocardiogram (ECG) without clinically significant abnormalities
4.Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasting blood sugar (FBS), blood urea nitrogen (BUN), creatinine (Cr), and liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and alkaline phosphatase (ALP)) must be within the normal range or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
5.PT and aPTT should be within normal range or showing no clinically significant abnormalities in the opinion of clinical investigator.
6.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
7.Must have serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus antibody (anti-HIV) seronegative
8.Female subject must have serum beta-subunit of human chorionic gonadotropin in serum (beta-hCG) negative.
9.Female subject who is childbearing potential or male subject agrees to use an acceptable birth control method from visit 1 to the follow-up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow-up visit. Hormonal contraceptives are not acceptable.
10.Female subject who is non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea))
11.Female subject must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing at Period 1 and Period 2.
12.Non-smoker (never smoked or no smoking within the previous 1 year)
13.Refrain from using herbal medications, cannabis containing products, dietary supplements , vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of investigational product (Day 1). Subjects must agree to refrain from these items until the last collection time-point of Period 2.
14.Subject must have ended any medications at least 30 days prior to Day 1 or at least 5 times of elimination half life prior to Day 1 and agree to continue their refraining throughout the follow-up period.
15.Subject does not receive Coronavirus Disease-19 (COVID-19) vaccine within 14 days before screening visit and does not plan to receive COVID-19 vaccine until the follow-up period.
16.Subject must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-poi
1.Known hypersensitivity to rivaroxaban or any other similar class of drugs or its components
2.Past medical history of renal and hepatic insufficiency
3.Subject has a history of any illness that, in the opinion of Principal/Clinical Investigator or designated physicians, might confound the result of the study or pose an additional risk in administering investigational product to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
4.Have a history of significant hemorrhage within 6 months
5.Known of coagulation disorders (this may include but is not limited to hemophilia) or sensitive to common cause of bleeding
6.Have condition associated with an increase risk of bleeding. This may include but is not limited to: periodontitis, hemorrhoids acute gastroenteritis and acute peptic ulcer.
7.Have CrCl =50 mL/min
8.Have history of drug abuse (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
9.Have positive result of urine drug abuse testing on opioids (morphine (Mor), methadone (MTD)), cannabinoids (tetrahydrocannabinol (THC)), methamphetamine (Meth), cocaine (Coc) and methylenedioxy-methamphetamine (MDMA) at screening visit or before dose administration at each period
10.Alcohol abuse or excessive use (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
11.Have positive result of alcohol breathing test at screening visit or before dose administration at each period
12.Female subject is pregnant or breast feeding.
13.Difficulties fasting or consuming high-fat, high-calorie meals or standard meal
14.Difficulties swallowing whole tablets
15.Donation or loss of whole blood:
a.=50 mL and =499 mL within 30 days prior to Day 1
b.=500 mL within 56 days prior to Day 1
16.Participation in any investigational drug study within 30 days from screening visit (from the last follow-up visit to the screening visit). Subject who participates in COVID-19 vaccine trial that does not have any intervention during the course of this study (from the expected enrollment date to the expected follow-up visit) can be included in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameters (Cmax, AUClast, AUCinf) 0.000, 0.167, 0.333, 0.667, 1.000, 1.333, 1.667, 2.000, 2.333, 2.667, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 10.000, 12.000, 16.000, 24.000 and 36.000 hours Rivaroxaban plasma concentration
- Secondary Outcome Measures
Name Time Method /A N/A N/A