Bioequivalence Study in Healthy Thai Volunteers. Vildagliptin 50 mg Tablets in Healthy Thai Volunteers.
Conditions
Interventions
Each tablet contains 50 mg of vildagliptin.,Vildagliptin 50 mg tablet, GALVUS, Reg. No. 1C 14/59 (N), manufactured by Novartis Farmaceutica S.A., Barbera del Valles, Spain and imported by Novartis (Th
Experimental Drug,Active Comparator Drug
Test (T): Vildagliptin 50 mg tablet,Reference (R): Vildagliptin 50 mg tablet, GALVUS
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/m2 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 consent (signed and dated) by the subject prior to participating in this study
Exclusion criteria
Exclusion criteria: 1.History of allergic reaction or hypersensitivity to vildagliptin or to any of the excipients 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo/hypertension), psychiatric, neurologic (e.g. seizures), 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 first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period 5.History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis 6.Have abnormality of glucose (FBS) 7.Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening 8.History or evidence of acute pancreatitis 9.History or evidence of jaundice 10.History or evidence of bullous pemphigoid or exfoliative skin lesion 11.History or evidence of heart failure 12.History or evidence of cardiovascular bleeding, gastrointestinal bleeding, gastric or duodenal or peptic ulcer 13.Have renal creatinine clearance (CrCl) <50 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test 14.History of sensitivity to heparin or heparin-induced thrombocytopenia 15.History of problems with swallowing tablet or capsule 16.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vildagliptin plasma concentration 0-24 hrs post dose Cmax, AUC0-tlast and AUC0 to infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Vildagliptin plasma concentration 0-24 hrs post dose Tmax, t1/2, AUC0-tlast/AUC0-infinity and MRT | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co.,Ltd.
Outcome results
None listed