The study is conducted in healthy Thai human volunteers to prevented anticoagulant. Bioequivalence Dabigatran Etexilate capsules 150 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Dabigatran Etexilate capsules 150 mg with 250 mL of drinking water and at least 7 days washout period be
Experimental Drug,Active Comparator Drug
Dabigatran Etexilate capsules 150 mg,PRADAXA 150 MG
Sponsors
Bio-innova Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai subjects are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2. 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 10 mL of blood for monitoring subjects safety after the completion of the study. 5. Negative urine pregnancy test for women and no breast-feeding. 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Dabigatran, Dabigatran Etexilate, Non-vitamin K antagonist oral anticoagulants (NOACs) e.g. apixaban, rivaroxaban and edoxaban, Proton pump inhibitor e.g. pantoprazole, omeprazole, rabeprazole and esomeprazole or any of the excipients of this product. 2. Subject with B.P. is Systolic B.P < 90, >= 140 mm/Hg, Diastolic B.P < 60, >= 90 mm/Hg or pulse rate > 100 beats per minute. 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).* 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).* 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).* 6. Positive of hepatitis B or C virus. 7. Have more than one abnormal EKG, which is considered as clinically significant. * 8. History or evidence of heart (unstable angina pectoris, myocardial infarction, cardiovascular, valvular heart disease, mechanical prostatic heart valve), stroke, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, diabetes mellitus with vascular disease, gout disease, hypertension or glaucoma. 9. History or evidence of gastrointestinal disorder likely to influence drug absorption, GI bleeding, GI ulcer or previous GI surgery other than appendectomy. 10. Active pathological bleeding before the study drug administration and until the completion of the study. 11. Surgery performed 1 month before the study drug administration or planned during the study. 12. History or evidence of hematological disorders (such as anemia, thrombocytopenia, antiphospholipid syndrome (APS)) or bleeding disorders especially hemophilia and Von Willebrand disease. 13. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 14. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) are above normal range.* 15. Creatinine clearance (CrCl) value less than or equal to 50 mL/min. 16. History of psychiatric disorder. 17. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 18. History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study. 19. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 20. History of grapefruit, pomelo or grapefruit products consumption and cannot stop at least 7 days before the study drug administration and until the completion of the study. 21. History of St. Johns Wort or St. Johns Wort product consumption and cannot stop at least 7 days before the study drug administration and until the completion of the study. 22. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 23. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration, area under the plasma concentration curve from dosing to last observed concentration at time t, area under the plasma concentration curve extrapolated to infinite time (0.00 hour) and at 0.17, 0.33, 0.50, 0.75, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours Pharmacokinetics parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; Adverse events (day 0), pre-dose (day1-5), at approximately 0.5, 1.0, 2.0, 3.0, 6.0, 12.0, 24.0, 36.0, 48.0, and 72.0 hours post-dose (day 5) Safety monitoring, vital sign | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed