food-effect bioavailability of fixed dose combination zemimet® sr tab. 50/1000 mg under fed and fasting conditions

Conditions: Type2 Diabetes

Summary: a randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods. a: fixed dose combination zemimet® sr tab. 50/1000 mg orally administered once without food (fasting conditions) b: fixed dose combination zemimet® sr tab. 50/1000 mg orally administered once with food (fed conditions)

\[objectives\] primary: to investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg fdc tablet (zemimet® sr tab. 50/1000 mg) in healthy subjects under fed and fasting conditions secondary: to evaluate safety of investigational product under fed and fasting conditions \[admission and confinement\] fed conditions: subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard hfhc breakfast and in-house stay until 24 hours post-dose. fasting conditions: subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.

Eligibility criteria:
inclusion criteria: * body mass index between 18.0 to 30.0 kg/m2. * normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. * non-pregnant woman (negative pregnancy test) and not currently breast feeding. * female subjects abstain from either hormonal methods of contraception * male subjects who are willing or able to use effective contraceptive * have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study exclusion criteria: * history serious hypersensitivity reactions * history or evidence of clinically significant diseases or any significant ongoing chronic medical illness * history or evidence of family diabetes * history or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma * history or evidence of shock or severe dehydrate or severe infection such as respiratory tract infection, urinary tract infection within 14 days prior to admission in each period * history or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period * history or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse * history of problems with swallowing tablet or capsule * difficulty fasting or consuming standardized meals * history of sensitivity to heparin or heparin-induced thrombocytopenia * any condition possibly affecting drug absorption * have renal creatinine clearance (clcr) \< 45 ml/min based on serum creatinine results at the screening laboratory test * 12-lead ecg demonstrating qtc \>450 msec, a qrs interval \>120 msec or with an abnormality considered clinically significant at screening.