Bioequivalence between vildagliptin/metformin 50 mg/1000 mg film-coated tablets (test product) and Galvusmet® 50 mg/1000 mg film-coated tablets (reference product), in healthy, adult, human subjects under fed conditions Not Applicable
Conditions
Interventions
The randomization plan is prepared by the Triumpharma pharmacy unit using SAS ® 9.4 program as per Triumpharma internal SOP no.: PHU-1104 "SOP title: Randomization plan preparation and drug assignment
Sponsors
Alpha Pharma
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy adult subjects from the Jordan population, 18 to 50 (inclusive) years old
Exclusion criteria
Exclusion criteria: 1. The subject is pregnant or nursing (lactating), where pregnancy is defined as the state of the female after conception and until the termination of gestation, confirmed by a positive urine or serum pregnancy test at screening and on admission day (before admission) of period I. 2. The subject has evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements at screening or on admission day (before admission) of period I. 3. The subject has a known history or presence of any clinically significant abnormality/pathology/disease in any of the body systems at screening or on admission day (before admission) of period I. 4. The subject has any significant physical or organ abnormality as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission) of period I. 5. The subject has difficulty swallowing at screening or on admission day (before admission) of period I. 6. The subject has a clinically significant history or presence of any clinically significant pathology (e.g. chronic diarrhea), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, metabolism or excretion of the drug as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission) of period I. 7. The subject has a known allergy to the drug under investigation (vildagliptin/metformin), or to any ingredient in the preparation (sodium starch glycolate, Avicel DG “dry granulation excipient-microcrystalline cellulose and anhydrous dibasic calcium phosphate”, hydroxypropyl cellulose, magnesium stearate, titanium dioxide, triacetin, iron oxide yellow, hypromellose, lactose monohydrate, fd&c yellow #6 sunset yellow aluminium lake, d&c yellow #10 aluminium lake, ferric oxide red, polyethylene glycol, and talc). 8. The subject has a history of hypersensitivity to heparin as checked at screening. 9. The subject suffered from a major illness (as per the principal investigator/clinical sub-investigator judgment) within one month preceding the screening procedure. 10. The subject has a history of or current compulsive abuse of alcohol or regular exposure to other substances of abuse at screening and on admission day (before admission) of period I. 11. The subject has a positive test for illicit drugs or alcohol on admission day (before admission) of the first period. 12. The subject is a moderate smoker (more than 10 cigarettes per day) at screening and on admission day (before admission) of period I. 13. The subject is on a special diet (for example the subject is a vegetarian, low salt food), or dieting (on a weight-lowering plan) during the month preceding the first dosing as checked at screening. 14. The subject as checked at screening and on admission day (before admission) of period I will consume alcohol or caffeine or related xanthine-containing foods or beverages such as caffeine in tea, coffee, chocolates, cola and Pepsi within 48 hours prior to first dosing. 15. The subject will use any prescribed medication during the last four weeks or OTC medicinal products, vitamins or herbal medications during the last two weeks preceding first dosing as checked at screening and on admission day (before admission) of period I.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bioequivalence of vildagliptin/metformin 50 mg/1000 mg film-coated tablets (test product, Alpha Pharma, Kingdom of Saudi Arabia) and Galvusmet® 50 mg/1000 mg film-coated tablets (reference product, Novartis Pharma, Switzerland), in healthy adult subjects under fed conditions. A validated (liquid chromatography with tandem mass spectrometry [LC-MS/MS]) method of analysis is used to analyze vildagliptin and metformin in human plasma samples with a lower limit of quantification (LLOQ) of 0.50 ng/ml for vildagliptin and 20.00 ng/ml for metformin. A total of 19 blood samples were collected for this study in tubes containing lithium-heparin according to the following schedule: pre-dose (BK) "1 sample", 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours post-dosing in each study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerability of a single dose administered in healthy human adult subjects under fed conditions, measured using: 1. Full vital signs (blood pressure, pulse rate, and body temperature) measured, in a sitting position, at pre-dosing and at the following times: 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, and 24.00 hours post-dosing in each study period 2. Glucose blood test performed at 1 h before dosing, every 30 minutes during the first 4 hours post-dosing, and 5 h, 6 h, 7 h, 8 h, 12 h, and 24 h post-dosing 3. A final examination at the end of period II including vital signs, physical examination, ECG, and clinical laboratory examinations (full blood count, clinical chemistry, and urinalysis) | — |
Countries
Jordan
Contacts
Public ContactIyad Eqtefan
Outcome results
None listed