Thai healthy male and female subjects , Aged 18 to 55 years , BMI were within 18-30 kg/m2 , Good health confirming by physical and clinical. Empagliflozin, Bioequivalence study
Conditions
Interventions
a single oral of generic product, empagliflozin 25 mg film-coated tablet, under fasting condition, 28 subjects cross over with arm 2,a single oral of innovator product, empagliflozin 25 mg film-coated
Experimental Drug,Experimental Drug
Empagliflozine, generic product,Empagliflozine, innovator product
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Subjects who are Thai male and female, aged 18 to 55 years. 2.Subjects whose BMI are 18.0-30.0 kg/m2. 3.Subjects who are healthy by medical history, physical examination, vital signs. 4.Normal / acceptable 12-lead electrocardiographic results at least after 5 minutes of rest. 5.Subject whose screening visit laboratory tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, albumin is within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator. 6.For female subjects: Female subject who is in childbearing potential must have negative for urine pregnancy test and agrees to use an acceptable birth control method from the entire participation period to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable. Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea). 7.Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH (Follicle Stimulating Hormone) above 40 U/L and estradiol below 30 ng/L is confirmatory). 8.Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects who are with a history/evidence of drug sensitivity or allergic reaction to empagliflozin, or any related drug. 2.Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating study drug to the subjects. 3.Subjects who regularly consume drinks with tea, caffeine, caffeinated beverages and/or grapefruit juice and cannot omit those drinks during the study at least 3 days prior to the study period 1 day 0 to the completion of the study period 2. 4.Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least 14 days before the study period 1 day 0 and until the completion of the study period 2. 5.Subjects who are with a history of alcoholic (more than 2 years) or for women, who consumes more than 3 drinks on any single day and more than 7 drinks per week, for men, who consumes more than 4 drinks on any single day and more than 14 drinks per week and cannot omit alcohol intake at least 7 days before the study period 1 day 0 and until the completion of the study period 2 or alcohol breath test is positive. 6.Subjects who are with a history of any positive test for drug abuse (morphine, methamphetamine and marijuana) on the enrollment day of each period (strip test). 7.Subjects who receive of any medical prescription, herbal medicine and food supplement within 14 days before the first administration of the study drug, especially drug related to the study drug metabolizing enzymes. 8.Female subjects who are pregnant or breast feeding. 9.Subjects who are participating in any investigational drug study or had been in any investigational drug study within 3 months prior to check in period 1. 10.Those who donated or lose massive blood within 3 months before the study (> 450 ml). 11.Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. 12.Subjects who are positive for COVID-19 test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence 12 months 90% confidence interval of Cmax, AUC0-t and AUC0-inf | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters 12 months Cmax, Tmax, AUC, Half-life | — |
Countries
Thailand
Contacts
Public ContactNantaporn Prompila
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed