A Bioequivalence Study of Two Formulations of Rivaroxaban 20-mg Tablets, RELVAXA 20 and Xarelto 20 mg, in Healthy Thai Volunteers under Fed Conditions

Phase 1

• Conditions: Healthy; Bioequivalence study; Rivaroxaban Pharmacokinetics

• Registration Number: TCTR20240813002
• Lead Sponsor: T.O. Chemicals (1979) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-13
• Last Update Posted: 19 August 2024
• Study Completion: 2024-10-03

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1.Thai Male/Female must be 18-55 years of age, body weight more than 50 kg with BMI of 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 and not over 139 mmHg, diastolic blood pressure not lower than 60 and not over 89 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 ECG without clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians
4.Screening visit laboratory values of blood test including hematology (CBC with differential), FBS, BUN, Cr and liver function test (AST, ALT, total bilirubin and 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 in the opinion of Principal/Clinical Investigator or designated physicians
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 HBsAg, anti-HCV and anti-HIV negative.
8.Female subject must have serum beta-hCG negative or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
9.Female subject of childbearing potential or male subject agrees to use an acceptable birth control method from Screening Visit 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 Screening Visit to Follow-up Visit. Hormonal contraceptives are not acceptable.
10.Female subject of 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 each period.
12.Non-smoker (never smoked or no smoking within the previous 1 year as judged by medical history)
13.Refrain from using herbal medications, cannabis containing products, 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 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 systemic medications or any medications that have any impact on gastrointestinal system 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 Follow-up period.
15.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-point of Period 2.
16.Have the ability to understand the requirements of the study and must voluntarily sig

Exclusion Criteria

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.CrCl equal to or less than 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 (Mor, MTD), cannabinoids (THC), Meth, Coc or 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 standard high-fat, high-calorie meal or standard meals
14.Difficulties swallowing whole tablets
15.Donation or loss of whole blood:
a.equal or more than50 mL and equal ot less than499 mL within 30 days prior to Day 1
b.equal or more than 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 of the previous study to Screening Visit of this study).

Study & Design

• Study Type: Interventional
• Study Design: Not specified