A Single-Dose, Randomization Blinding, Two Period, Two Sequence Crossover Bioequivalence Study of Sitagliptin / Metformin Hydrochloride Tablets 50 mg / 500 mg and Reference Product (JANUMETTM Tablets 50 mg / 500 mg) in Healthy Thai Volunteers under Fed Conditions
- Conditions
- Bioequivalence Study in Healthy Thai VolunteersSitagliptin / Metformin Hydrochloride Tablets 50 mg / 500 mg in Healthy Thai Volunteers
- Registration Number
- TCTR20220302002
- Lead Sponsor
- International Bio Service Co.,Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 36
1.Healthy Thai male or female subjects between the ages of 18 to 55 years. Subject must meet age requirements at the time of signing the initial informed consent and at the dosing day in Period 1.
2.Body mass index between 18.0 to 30.0 kg 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-smoker and non-consumer of nicotine containing products
Non-smoker or non-consumer of nicotine containing products means any subject who has never smoked/consumed or stopped for at least 90 days.
5.Non-pregnant woman (negative pregnancy test) and not currently breast feeding
6.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 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
7.Male subjects who are willing or able to use effective contraceptive condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
8.Able to understand and voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
9.Adequate venous access in both arms for the collection of a number of samples during the study
10.Willing to follow precautions during driving and when using machines due to dizziness and somnolence have been reported.
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 ( hyper or 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) less than 45 mLper 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma Sitagliptin- Metformin concentration 0-72 hrs Cmax, AUC0-tlast and AUC 0-infinity
- Secondary Outcome Measures
Name Time Method Plasma Sitagliptin- Metformin concentration 0-72 hrs Tmax, t1/2 and The terminal elimination rate constant