Status:
COMPLETED
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
Lead Sponsor:
Dexa Medica Group
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects. The objective of...
Detailed Description
The objective of this study was to compare whether the bioavailability of PT Dexa Medica's formulation of rivaroxaban 20 mg film-coated tablet is equivalent to that of the comparator drug (Xarelto® 20...
Eligibility Criteria
Inclusion
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study.
- Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation.
- Aged 18 - 55 years inclusive.
- Non-smokers.
- Body mass index within 18 to 25 kg/m2.
- Vital signs (after 10 minutes rest) must be within the following ranges:
- Systolic blood pressure: 100 - 129 mmHg
- Diastolic blood pressure: 60 - 84 mmHg
- Pulse rate: 60 - 90 bpm.
- Willing to practice abstention or contraception during the study.
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) values should be within normal range.
- Normal renal function with acceptable creatinine clearance (CrCl) \>50 mL/min.
Exclusion
- History of allergy or hypersensitivity or contraindication to rivaroxaban or factor Xa inhibitors or allied drugs.
- Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness.
- Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration \> 1.4 mg/dL and ureum ≥ 1.5 ULN), etc.
- Patient with significant liver disease (severe hepatic impairment/Child Pugh C).
- Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
- Positive result for COVID-19 rapid antigen test (this criteria only applied if the study conduct during pandemic condition).
- Clinically significant hematology abnormalities.
- Clinically significant electrocardiogram (ECG) abnormalities.
- Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery.
- Past history of anaphylaxis or angioedema.
- History of drug or alcohol abuse within 12 months prior to screening for this study.
- Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day.
- History of any bleeding or coagulative disorders.
- History of significant head or spinal cord injury or recent surgery on the brain, spinal cord or eyes.
- Presence of difficulty in accessibility of veins in left or right arm.
- A donation or significant blood loss within 90 days before this study's first dosing day.
- Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study's first dosing day.
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06558045
Start Date
July 6 2023
End Date
October 2 2023
Last Update
August 16 2024
Active Locations (1)
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1
PT Equilab International
Jakarta, Indonesia, 12430