Bioequivalence Study in Healthy Thai Volunteers Sitagliptin / Metformin Hydrochloride 50 / 500 mg in Healthy Thai Volunteers
Conditions
Interventions
Generic sitagliptin/metformin hydrochloride 50/500 mg fixed dose combination film-coated tablet.
Each tablet contains sitagliptin 50 mg /metformin hydrochloride 500 mg ,Reference (R): Sitagliptin/met
Experimental Drug,Active Comparator Drug
Test (T) :Generic sitagliptin/metformin hydrochloride 50/500 mg fixed dose combination film-coated tablet,Reference (R) : sitagliptin/metformin hydrochloride 50/500 mg fixed dose combination film-coa
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 per square meter 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. 5.5.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 sitagliptin, metformin or any other component 2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), 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 COVID-19 vaccine within 30 days prior to check-in in each Period. 5.Have renal creatinine clearance (CrCl) < 60 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test 6.History or evidence of acute or chronic metabolic acidosis including diabetic ketoacidosis or lactic acidosis 7.History or evidence of acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis 8.History or evidence of type 1 diabetes mellitus 9.History or evidence of heart failure 10.History or evidence of vitamin B12 deficiency 11.History or evidence of severe joint pain 12.History or evidence of bullous pemphigoid 13.Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening 14.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 15.History of sensitivity to heparin or heparin-induced thrombocytopenia 16.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy 17.History of diarrhea or vomiting within 24 hours prior to check-in in each period 18.History of problems with swallowing tablet or capsule 19.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine) 20.Investigation with blood sample shows positive test for HBsAg. 21.Abnormal liver function, more than 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test 22.12 lead ECG demonstrating QTc more than 450 msec, a QRS interval more than 120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject eligibility. 23.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Sitagliptin-Metformin concentration 0-72 hrs Cmax, AUC0-tlast and AUC 0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Sitagliptin-Metformin concentration 0-72 hrs Tmax, t1/2 AUC0-tlast/AUC 0-infinity | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed