An Open Label, Randomized, Two-Period, Single Oral Dose, Crossover Bioequivalence Study of RIBAROX (20 mg) (Rivaroxaban 20 mg tablets) of the GPO, Thailand with Xarelto (Rivaroxaban 20 mg tablets) of Bayer AG, Germany in Healthy, Adult Human Subjects under Fed Conditions
- Conditions
- Healthy male and female subjectsBioequivalence fed conditions
- Registration Number
- TCTR20220804009
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 32
1.Normal, healthy, adult, both males and females subjects between 18 and 55 years of age (both inclusive).
2.Having a Body Mass Index (BMI) between 18.0 and 30.0 (both inclusive), calculated as weight in kg/height in m2.
3.Subject whose clinical laboratory values are within normal/acceptable reference ranges or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. If any subject has values outside of the pre-defined normal/acceptable range, the study physician/ Principal Investigator should have a clearly documented and medically rigorous justification for making that exception.
4.Normal medical history, clinical examination, 12 lead ECG, and chest X-ray recordings (during the last 6 months) (postero-anterior view).
5.Able to understand and comply with the study procedures, in the opinion of the investigator.
6.Able to give voluntary written informed consent for participation in the trial.
7.In case of female subjects:
-Surgically sterilized at least 06 months prior to study participation;
Or
-If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
And
-Urine pregnancy test must be negative.
1)Known hypersensitivity to rivaroxaban or any excipients or any related drug or any substance.
2)History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
3)Subjects who are being or have previously been treated for any GI problems or convulsive, depressive or hepatic disorders, and in whom there is a risk of a recurrence during the study period.
4)Ingestion or use of any medication [prescribed medication & over the counter (OTC) medication including herbal remedies and St. John Wort] at any time in 14 days prior to dosing of period-I. In any such case subject selection will be at the discretion of the Principal Investigator.
5)Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication.
6)Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in Period-I.
7)Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks) 24 hours prior to IMP administration of period-I.
8)Heavy smoking (greater than or equal to 10 cigarettes/day).
9)Moderate smoking (less 10 cigarettes/day) and consumption of tobacco containing products, which cannot stop smoking or consuming 24 hours prior to dosing and for entire duration of the study.
10)A recent history of harmful use of alcohol (less than 2 years), Ex: alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percent distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in Period-I.
11)The presence of clinically significant abnormal laboratory values during screening.
12)Use of any recreational drugs or history of drug addiction or testing positive in pre study drug scans.
13)History or presence of seizure or psychiatric disorder.
14)A history of difficulty with donating blood.
15)Difficulty in swallowing solids dosage forms like tablets or capsules.
16)Donation of blood (1 unit or 350 mL) within a period of 30 days prior to the first dose of study medication.
17)Receipt of an investigational medicinal product or participation in a drug research study within a period of 30 days prior to the first dose of study medication**.
** If investigational medicinal product is received within 30 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
18)Systolic blood pressure less 90 or greater than or equal to 140 mmHg or diastolic blood pressure less 60 or greater than or equal to 90 mmHg.
19)CrCl value less than 50 mL/min.
20)PT and aPTT results above the normal range.
21)History or presence of bleeding disorders or active bleeding from any site or any other clinically significant bleeding risk as judged by Principal Investigator/Co-Investigator.
22)Subjects having hereditary problems of lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
23)A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
24)A positive test result for HIV.
25)A positive result for COVID-19 rapid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90 % CI pharmacokinetic parameters derived from drug plasma 23 blood sampilng time points (pre-dose (0.000) and 0.5, 1, 1.333, 1.667, 2, 2.333, 2.667, 3, 3.333, 3.667, 4, 4.333, 4.667, 5, 5.5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose ) bioanalysis and pharmacokinetic data analysis
- Secondary Outcome Measures
Name Time Method Adverse event/severe adverse event Vital signs will be measured (Pre-dose on day 1,2, 4, 8, 12,24,36,48 and 72 hrs post-dose. physical and biochemical examination