Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

Launched by LG CHEM · Mar 19, 2020

Keywords

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Gender

ALL

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
• • 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
• • 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