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

LG Chem

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes

Treatments

Drug: Gemigliptin tartrate sesquihydrate and metformin

Drug: gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release

Study type

Interventional

Funder types

Industry

Identifiers

NCT04317703

LG-DMCL009

Details and patient eligibility

About

To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) and coadministration of corresponding dose of gemigliptin 50 mg (Zemiglo Tablet 50 mg) and metformin hydrochloride 1000 mg prolonged release (Glucophage XR 1000 mg) as individual tablet in healthy subjects under fasting conditions

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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