Healthy male and female subjects Healthy male and female subjects Bioequivalence Dapagliflozin 10 mg tablet Fasting
Conditions
Interventions
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.,Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg of dapagliflozin.
Experimental Drug,Active Comparator Drug
GPO DAPA 10 mg tablet,forxiga 10 mg tablet
Sponsors
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Non-smokers, normal, healthy, adult, both males and females subjects between 18 and 55 years of age (both inclusive). 2) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg/height in m2. 3) Subject whose clinical laboratory values are within normal/acceptable reference ranges or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. If any subject has values outside of the pre-defined normal/acceptable range, the study physician/ Principal Investigator should have a clearly documented and medically rigorous justification for making that exception. 4) Subject whose medical history, clinical examination, 12 lead ECG, and chest X-ray recordings (postero-anterior view) are normal or clinically insignificant during screening as determined by physician or principal investigator to be of no clinical significance. 5) Able to understand and comply with the study procedures, in the opinion of the investigator. 6) Able to give voluntary written informed consent for participation in the trial. 7) In case of female subjects: 7.1 Surgically sterilized at least 06 months prior to study participation; or 7.2 If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. And 7.3 Urine pregnancy test must be negative.
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to dapagliflozin or any excipients or any related drug or any substance. 2) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 3) Subjects who are being or have previously been treated for any GI problems or convulsive, depressive or hepatic disorders, and in whom there is a risk of a recurrence during the study period. 4.) Ingestion or use of any medication, including prescription medicines, over the counter medicines, herbal remedies, or St John Wort, at any time within 14 days before dosing in period I. In such cases, subject selection will be at the discretion of the Principal Investigator. 5) Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication. 6) Consumption of grapefruits and grapefruit products within a period of 72 hours prior to dosing in period-I. 7) Consumption of xanthine containing food or beverages (tea, coffee, chocolates or cola drinks) tobacco, tobacco containing products 24 hours prior to IMP administration of period-I. 8) Smokers or who have smoked within last 6 months prior to start of the study. 9) A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 48 hours prior to dosing in period-I. 10) The presence of clinically significant abnormal laboratory values during screening. 11) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 12) History or presence of seizure or psychiatric disorder. 13) A history of difficulty with donating blood. 14) Difficulty in swallowing solids dosage forms like tablets or capsules. 15) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication. 16) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**. ** If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received. 17) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies. 18) A positive test result for HIV antibody (1 &/or 2). 19) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to receiving the study drug in period-I. In any such case subject selection will be at the discretion of the Principal Investigator. 20) Nursing mothers (for female subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration time curve and Maximum plasma concentration Pre dose and up to 48 hours post dose Plasma drug concentration determined by validated LC MS MS method | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum concentration Pre dose and up to 48 hours post dose Plasma drug concentration determined by validated LC MS MS method,Pharmacokinetic parameters of dapagliflozin: AUC0_to_t, AUC0_to_infinity, Cmax, Tmax, Lambda_z, t_half, AUC0_to_t_over_AUC0_to_infinity, and AUC_percent_extrapolated_observed Pre dose and up to 48 hours post dose Plasma drug concentration determined by validated LC MS MS method,Safety parameters Screening, pre dose, during study, and at study completion Adverse events, vital signs, physical examination, clinical laboratory tests, ECG | — |
Countries
Thailand
Contacts
Public ContactDr. Porranee Puranajoti
International Bio Service Co.,Ltd.
Outcome results
None listed