Bioequivalence Study of Generic Apixaban Tablet 5 mg

Phase 1

Completed

• Conditions: Healthy subjects; Bioequivalence; Apixaban

• Registration Number: TCTR20230621009
• Lead Sponsor: Duopharma Biotech Berhad

Brief Summary

The 90% confidence interval of Cmax, AUC0-t and AUC0-inf were within bioequivalence acceptance limit of 80-125%. Apixaban Tablet 5 mg is bioequivalent to reference product

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-05
• Study Start: 2023-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Able to participate, communicate well with the investigators, and would provide written informed consent to participate in the study
2. Healthy male and female subjects with the 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
3. Aged 18-55 years inclusive
4. Non smokers
5. Body mass index within 18.5 to 30 kg/m3
6. Normal prothrombin time (PT) and normal partial thromboplastin time (aPTT)
7. Creatinine clearance > 50 mL/min
8. Vital sign (after 10 minute rest) we were within the following ranges
i. Systolic blood pressure: 100-129 mmHg
ii. Diastolic blood pressure: 60-84 mmHg
iii. Pulse rate: 60-90 bpm

Exclusion Criteria

1. History of allergy or hypersensitivity or contraindication to apixaban or factor Xa inhibitors or allied drugs.
2. Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug).
3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness
4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test, renal function test etc
5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV.
6. Positive result for COVID-19 swab antigen test.
7. Clinically significant hematology abnormalities.
8. Clinically significant electrocardiogram (ECG) abnormalities
9. 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.
10. Past history of anaphylaxis or angioedema
11. History of drug or alcohol abuse within 12 months prior to screening for this study.
12. Participation in any clinical trial within the past 90 days calculated from the last visit until this study's first dosing day
13. History of any bleeding or coagulative disorders.
14. History of significant head injury within the last two years
15. Presence of difficulty in accessibility of veins in left or right arm.
16. A donation or significant blood loss within 90 Presence of difficulty in accessibility of veins in left or right arm.
16. A donation or significant blood loss within 90 days before this study first dosing day.
17. Intake of any prescription (especially apixaban, other anticoagulants, azole antimycotics), non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study first dosing day.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic pre dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 9.00, 12.00, 24.00, 36.00, 48.00, and 72.00 hours The area under curve (AUC) and Maximum concentration (Cmax) will be calculated

Secondary Outcome Measures

Name	Time	Method
Safety pre dose, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 9.00, 12.00, 24.00, 36.00, 48.00, and 72.00 hours To monitor the safety of the subjects and tolerability of single dose formulation