Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions

NCT ID: NCT04070794

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2019-12-30

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FDC Zemimet® SR Tab. 50/1000(Fasting)

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

Group Type: ACTIVE_COMPARATOR

Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)

Intervention Type: DRUG

Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours.

FDC Zemimet® SR Tab. 50/1000(Fed)

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

Group Type: ACTIVE_COMPARATOR

Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)

Intervention Type: DRUG

Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast.

Interventions

Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)

Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours.

Intervention Type: DRUG

Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)

Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uthai Suvanakoot

Role: PRINCIPAL_INVESTIGATOR

International Bio Service Co., Ltd.

Central Contacts

Eunjoo Cho

Role: CONTACT

eunjoo.cho@lgchem.com

+82-2-6987-4284

Sirin Khantichaikajon

Role: CONTACT

sirink@lgchem.com

+66-2-654-2323 ext. 118

Other Identifiers

LG-DMCL008

Identifier Type: -

Identifier Source: org_study_id