Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
- Conditions
- Type2 Diabetes
- Interventions
- Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)
- Registration Number
- NCT04070794
- Lead Sponsor
- LG Chem
- Brief 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)
- Detailed Description
\[Objectives\] 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description FDC Zemimet® SR Tab. 50/1000(Fasting) Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting) Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fasting condition FDC Zemimet® SR Tab. 50/1000(Fed) Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed) Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fed condition
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose. The observed maximum or peak concentration after administration of the drug
AUC0-tlast of gemigliptin, LC 15-0636 and metformin Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose. Area under the concentration-time curve from time zero to the last time where plasma concentration can be measured
AUC0-∞ of gemigliptin, LC 15-0636 and metformin Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose. Area under the concentration-time curve from time zero to infinity by the extrapolation of the rest of AUC from last time where plasma concentration can be measured to time infinity
- Secondary Outcome Measures
Name Time Method