The study is conducted in healthy Thai human volunteers to treatment of thrombocytopenia Bioequivalence Eltrombopag 50 mg tablets
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive
a single dose of Eltrombopag 50 mg tablets with 250 mL of water.,The marketed original products which were already availa
Experimental Drug,Active Comparator Drug
Eltrombopag 50 mg tablets,REVOLADE Film-coated tablets 50 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 participating 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, compliance with the requirements of the entire protocol and consent to the blood collection by investigators of approximately 10 mL for the screening process and approximately 7 mL of blood for monitoring the 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 Eltrombopag 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), stroke, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, diabetes mellitus with vascular disease, gout disease, hypertension, cataract or glaucoma. 9. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 10. History or evidence of abnormal hepatic function. 11. History or evidence of risk factors for thromboembolism (eg., factor V Leidon, ATIII deficiency, antiphospholipid syndrome). 12. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 13. History of psychiatric disorder. 14. 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. 15. 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. 16. High caffeine/xanthine 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. 17. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 18. 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 supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the first dose of study medication. 19. History of difficulty in accessibility of veins in left and right arm. 20. Blood donation (one unit or 450 mL) within the past 3 months before the study. 21. Participation in any clinical study within the past 3 months before the study. 22. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Eltrombopag level 0.00,0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours UPLC-MS/MS | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign (Systolic BP, Diastolic BP, Pulse) pre-dose, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours Vital sign (Systolic BP, Diastolic BP, Pulse) | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed