Healthy voluneers
Conditions
Interventions
Product Name: Test 1: Dapagliflozin 10 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
Product Name: Test 2: Dapagliflozin 10 mg film-coated tablets
Product Code: NA
Pharmaceutical For
Sponsors
KRKA, d.d., Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged between = 18 to = 55, Caucasian race. 2. Body mass index (weight/height²) in the range 18.5 to 30 kg/m². 3. Non-smokers or ex-smokers, where an ex-smoker is defined as someone who did not use nicotine/tobacco-containing products in the last 6 months prior to screening. 4. A female volunteer must meet one of the following criteria: a) Participant is of childbearing potential and agrees to use one of the accepted contraceptive regiments from at least 28 days prior to the first administration of the study medication, during the study and for at least 30 days after the last dose of the study medication. b) Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses) 5. Able to communicate and co-operate with the investigator and his staff. 6. Capable of consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with positive answer to any of the following will not be eligible to enter the study: At screening: 1. History of alcohol and/or drug abuse within one year prior to the screening. 2. Ongoing or history of clinically significant chronic illness (especially type 1 and type 2 diabetes mellitus, hypotension, genital or urinary tract infections). 3. Any clinically significant illness within 28 days prior to scheduled first administration of study medication. 4. Clinically significant abnormalities: a. of medical history (especially diabetes, cardiac failure (including family history), hypotension, renal and hepatic impairment, conditions that may lead to increased risk of diabetic ketoacidosis, recent or recurrent history of diabetic ketoacidosis, perineal abscess, necrotising fasciitis of the perineum), b. on physical examination (especially intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness), c. of the ECG, d. of haematology, biochemistry or urinalysis results. 5. Positive test for HBsAg, anti-HCV, anti-HIV-1/HIV-2 at screening. 6. A depot injection or an implant of any drug (including hormone-releasing intrauterine device) within 90 days prior to scheduled first administration of study medication. 7. Participation in other clinical studies within 60 days prior to scheduled first administration of study medication. 8. Donation or loss of more than 450 mL of blood within 60 days, or donation of plasma or platelets within 14 days prior to scheduled first administration of study medication. 9. Seated diastolic blood pressure lower then 60 or higher than 90 mmHg , seated systolic blood pressure lower than 100 or higher than 140 mmHg. 10. Seated heart rate less than 55 or over 100 beats per minute. 11. Having a known sensitivity to study medications or any similar medications, including excipients. 12. Known history or presence of galactose intolerance, lactase deficiency or glucose-galactose malabsorption. 13. Use of any drugs known to induce or inhibit hepatic drug metabolism i.e. CYP3A4 inhibitors/inducers, CYP2D6 inhibitors (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 28 days prior to scheduled first administration of the study medication. 14. Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug. 15. Difficulties to swallow the study medication. 16. Unable or unwilling to comply with the provisions of this protocol. 17. Any reason which in opinion of the Medical Sub-investigator would prevent the volunteer from participating in the study. 18. For female subjects only: Females who use the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to scheduled first administration of study medication. 19. For female subjects only: Females who use hormone replacement therapy in the 28 days prior to scheduled first administration of study medication. 20. For female subjects only: Females who are pregnant or lactating. 21. For female subjects only: positive result of the serum pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare the rate and extent of absorption of dapagliflozin from two test formulations of Dapagliflozin 10 mg film-coated tablets administered as Treatment A and B versus reference formulation Forxiga® 10 mg film-coated tablets (dapagliflozin) administered as Treatment C, administered to healthy volunteers in a single-dose, randomized, 3-way cross-over study under fed conditions. ;Secondary Objective: Not applicable;Primary end point(s): Pharmacokinetcs - parameters for dapagliflozin AUCt, AUCi, Cmax, residual area (RAUC), Tmax, Thalf and Kel.;Timepoint(s) of evaluation of this end point: For dapagliflozin there will be a total of 23 blood samples taken per period: at predose and at 0.333, 0.667, 1, 1.333, 1.667, 2, 2.25, 2.5, 2.75, 3, 3.333, 3.667, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose (1 x 3 mL each). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Slovenia
Contacts
Public ContactDeputy Director of R&D Pharm for P
KRKA d.d.
Outcome results
None listed