Bioequivalence Study in Healthy Thai Volunteers Dapagliflozin 10 mg Film-coated Tablet in Healthy Thai Volunteers under Fasting Conditions
Conditions
Interventions
Each tablet contains dapagliflozin 10 mg,Each tablet contains dapagliflozin 10 mg film-coated tablet, ForxigaTM 10, Reg. No. 1C 64/57 (N), manufactured by AstraZeneca
Experimental Drug,Active Comparator Drug
Test (T): Generic dapagliflozin 10 mg film-coated tablet,Reference (R): Dapagliflozin 10 mg film-coated tablet, Forxiga
Sponsors
International Bio Service Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male or female subjects between the ages of 18 to 55 years 2. Body mass index between 18.0 to 30.0 kg per square meter 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study. 4. Non-pregnant woman (negative pregnancy test) and not currently breast feeding. 5. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: - Postmenopausal for at least 1 year or - Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months 6. Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2. 7. Have voluntarily given written informed consents (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to dapagliflozin or to any of the excipients 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19 4. History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period. 5. Have abnormality of glucose (FBS) 6. History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis 7. History or evidence of heart failure 8. History or evidence of volume depletion, hypotension, electrolyte imbalances 9. History or evidence of genital mycotic infections, urinary tract infections within 14 days prior to check-in in each period 10. History or evidence of necrotizing fasciitis of the perineum (fournier is gangrene) 11. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption 12. History or evidence of severe hepatic impairment 13. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 14. History of problems with swallowing tablet or capsule 15. History of sensitivity to heparin or heparin-induced thrombocytopenia 16. History of vomiting or diarrhea within 24 hours prior to check-in in each period 17. 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject is eligibility. 18. Investigation with blood sample shows positive test for HBsAg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dapagliflozin 0-72 hours Cmax, AUC0-tlast and AUC0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| dapagliflozin 0-72 hours Tmax, t1/2, AUC0-tlast/AUC0-infinity | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed