Healthy volunteers Bioequivalence Dapagliflozin Tablet 10 mg
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single dose of Dapagliflozin Tablet 10 mg with 240 +- 2 mL of 20% glucose solution in water.,The marketed original pro
Experimental Drug,Active Comparator Drug
Dapagliflozin Tablet 10 mg ,Forxiga tablets 10 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 participants are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30.0 kg/m2. 4. Comprehension of the nature and purpose of the study, compliance with the requirements of the entire protocol and agreement to allow investigators to collect approximately 10 mL of blood for screening and approximately 7 mL of blood for monitoring participants 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 based on the laboratory evaluations, medical history or prior surgeries during screening. Some laboratory values, e.g., complete blood count, that are outside the normal range will be carefully considered by physician.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Dapagliflozin or any of the excipients of this product. 2. Participant whose a 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, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, hypotension or glaucoma. 9. History or evidence of urinary tract infections (including urosepsis and pyelonephritis) or genital mycotic infection within 3 months prior to drug administration. 10. History or evidence of symptomatic episodes of hypoglycemia or hyperglycemia prior to drug administration in each period. 11. History that may predispose to ketoacidosis, including pancreatic insulin deficiency from any cause or severe starvation within 1 month prior to drug administration and until completion of the study. 12. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy. 13. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 14. History of psychiatric disorder. 15. 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. 16. History of regular smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) and cannot stop at least 7 days before the study drug administration and until the completion of the study. 17. 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. 18. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids). 19. 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. 20. History of difficulty in accessibility of veins in left and right arm. 21. Blood donation (one unit or 450 mL) within the past 3 months before the study. 22. Participate in any clinical study within the past 3 months before the study. 23. Participants who are unwilling or unable to comply with the lifestyle guidelines described in this protocol. (* Depend on decision of principal investigator and/or clinical investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Dapagliflozin level pre-dose (0.00 hour) and 0.25, 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 and 48.00 hours 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign (Systolic BP, Diastolic BP, Pulse) check-in, pre-dose, at approximately 1.0, 2.0, 4.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose Automatic blood pressure, Point of care glucose at approximately 2.0, 4.0, 24.0, 36.0 and 48.0 hours Blood glucose meter (Volunteer, Once) | — |
Countries
Thailand
Contacts
Public ContactSasitorn Kittivoravitkul
Bio-innova Co., Ltd
Outcome results
None listed