Bioequivalence Study for Gemigliptin/Metformin 50/1000 mg and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.

LG Chem

Status and phase: Unknown; Phase 1

Conditions: Type2 Diabetes

Treatments: Drug: gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release; Drug: Gemigliptin tartrate sesquihydrate and metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04050098

LG-DMCL007

Details and patient eligibility

About

[Objectives]Primary: 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 Secondary: To evaluate safety of test and reference formulations

Enrollment: 24 estimated 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Test: Gemigliptin/Metformin

Active Comparator group

Description:

Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg)

Treatment:

Drug: Gemigliptin tartrate sesquihydrate and metformin

Reference: Gemigliptin and Metformin

Active Comparator group

Description:

Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg)

Treatment:

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