A Bioequivalence Study of Two Formulations of 20-mg Rivaroxaban Tablets in Healthy Thai Volunteers under Fed Conditio
- Conditions
- Healthy volunteersBioequivalenceRivaroxabanPharmacokinetic study
- Registration Number
- TCTR20200513006
- Lead Sponsor
- ovartis (Thailand) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 40
1.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
3.Screening electrocardiography (ECG) without clinically significant abnormalities
4.Screening visit laboratory values of blood test including hematology (complete blood count (CBC) with differential), fasted 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.
5.Prothrombin time (PT) and activated partial thromboplastin time (aPTT) should be within normal range or showing no clinically significant abnormalities in the opinion of principal/clinical investigator.
6.Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of principal/clinical investigator.
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 subjects must have beta-subunit of human chorionic gonadotropin in serum (β-HCG) negative.
9.Female subject who is childbearing potential or male subject agree 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 (IUD) 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 subjects 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-smokers (never smoked or no smoking within the previous 2 years)
13.Refrain from using herbal medications, dietary supplements (e.g., St. John’s Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of study drug (Day 1). Subjects must agree to refrain from these items until the last collection time-point of period 2.
14.Subjects must have ended any medications at least 30 days prior to Day 1 and agree to continue their refraining throughout the follow-up period.
15.Subjects 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-point of period 2.
16.Have the ability to understand the requirements of the study and must volu
1.Known hypersensitivity to rivaroxaban, any other similar class of drugs and its excipients (lactose monohydrate, sodium laurilsulfate, hypromellose, croscarmellose sodium, magnesium stearate, cellulose, microcrystalline, silica, colloidal anhydrous (Aerosil))
2.Known of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
3.Past medical history of renal and hepatic insufficiency
4.Subject has a history of any illness that, in the opinion of the principal/clinical investigator, might confound the result of the study or pose an additional risk in administering study drug to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal (especially gastrointestinal ulcer), 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.
5.Have a history of significant hemorrhage within 6 months
6.Known of coagulation disorders (this may include but is not limited to hemophilia) or sensitive to common cause of bleeding
7.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.
8.Have CrCl ≤50 mL/min
9.Have history of drug abuse (in the opinion of the principal/clinical investigator, as judged by medical history) in the last 12 months.
10.Have positive result of urine drug abuse testing on opioids (morphine (Mor), methadone (MTD)), cannabiniods (tetrahydrocannabinol (THC)), methamphetamine (Meth), cocaine (Coc) and methylenedioxy-methamphetamine (MDMA) at screening visit or before dose administration at each period
11.Alcohol abuse or excessive use (in the opinion of the principal/clinical investigator, as judged by medical history) in the last 12 months.
12.Have positive result of alcohol breathing test at screening visit or before dose administration at each period
13.Female subject is pregnant or breast feeding.
14.Difficulties fasting or consuming standard high-fat and high-calorie meals
15.Difficulties swallowing whole tablets
16.Donation or loss of whole blood:
a.≥ 50 mL and ≤ 499 mL within 30 days prior to dosing
b.≥ 500 mL within 56 days prior to dosing.
17.Participation in any investigation drug study within 1 month from screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters: Cmax, AUC0-t and AUC0-inf up to 36 hours Rivaroxaban plasma concentration
- Secondary Outcome Measures
Name Time Method /A N/A N/A