A Single-dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Full Replicate Crossover Bioequivalence Study of Generic Edoxaban 60 mg Film-coated Tablets (Unison Laboratories Co., Ltd.) and Reference Product (Lixiana) in Healthy Thai Volunteers under Fasting Conditions
- Conditions
- Bioequivalence Study of Edoxaban 60 mg Film-coated Tablets in Healthy Thai Volunteers under Fasting Conditions
- Registration Number
- TCTR20230826003
- Lead Sponsor
- nison Laboratories Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 30
1. Healthy Thai male or female volunteers aged between 18 and 55 years.
2. The Body Mass Index (BMI) ranges from 18.5 to 25 kg/m2.
3. Determined healthy by medical history, physical examination and vital signs
4. The results of the clinical laboratory tests are within clinically acceptance limits i.e., blood urea nitrogen (BUN), serum creatinine, AST, ALT, total bilirubin, alkaline phosphatase, GGT, blood potassium, sodium, calcium, chloride, fasting blood sugar and hematology examinations including differential blood counts and HBsAg test. Some of the clinical laboratory values that out of the normal range will be carefully considered by clinical investigator.
5. BW is not less than 60 kg, CrCl is more than 50 mL/min, PT and aPTT are within normal range.
6. Negative pregnancy test for female volunteers and effective contraceptive must be used at least 14 days prior to the study initiation and not breast-feeding women.
7. Male volunteers who are surgically sterile or agree to use an effective contraception throughout the study.
8. Willing to participate in the study and signed the informed consent form.
1. History or evidence of allergy or hypersensitivity to edoxaban or any of the excipients of this product or any related drugs.
2. History or evidence of allergy or hypersensitivity to heparin.
3. History or evidence of hypertension (systolic BP 140 mmHg, diastolic BP 90 mmHg) or hypotension (systolic BP <90 mmHg, diastolic BP <60 mmHg).
4. History or evidence of gastrointestinal, hepatic, renal, cardiovascular, hematological disease or allergic disease or bronchial asthma or any disease that may affect the bioavailability of drug.
5. Evidence of more than one abnormal ECG which is considered as clinically significant.
6. History of chronic or debilitating diseases.
7. History of clinically significant active bleeding.
8. Positive HBsAg tests.
9. History of alcoholism or drug abuse.
10. Positive urine drug abuse tests (Benzodiazepines, Methamphetamine and Opiates).
11. History of regular alcohol consumption (more than 1 time a week) or alcohol consumption within 7 days prior to the study drug administration and until the completion of the study.
12. History of smoking more than 10 cigarettes/day, or moderate smokers (less than 10 cigarettes/day) and could not quit at least 7 days prior to the study drug administration and until the completion of the study.
13. Tea/coffee or caffeine- or xanthine-containing beverage consumption within 7 days prior to the study drug administration and until the completion of the study.
14. Grapefruit juice or grapefruit-containing products consumption within 7 days prior to the study drug administration and until the completion of the study.
15. Use of any prescription drugs or over-the-counter (OTC) drugs or herbal medicines within 30 days or vitamins or food supplements within 14 days prior to the study drug administration or use hormonal methods of contraception with-in 28 days (discontinuation for at least 6 months is required for Depo-Provera use) prior to receiving the first dose of the study medication.
16. Blood donation or blood loss over 350 mL within 90 days before the study.
17. Participation in any clinical studies within 90 days before the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Edoxaban concentration in Plasma 0 0.17 0.33 0.5 0.75 1 1.5 2 2.5 3 4 6 8 10 12 24 48 hours Cmax AUC0-t and AUC0-inf
- Secondary Outcome Measures
Name Time Method Edoxaban concentration in Plasma 0 0.17 0.33 0.5 0.75 1 1.5 2 2.5 3 4 6 8 10 12 24 48 hours Tmax T1/2 Kel and AUC0-t/AUC0-inf