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

Primary Purpose

Type2 Diabetes

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

FDC Zemimet® SR Tab. 50/1000(Fasting)

FDC Zemimet® SR Tab. 50/1000(Fed)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin

The observed maximum or peak concentration after administration of the drug

AUC0-tlast of gemigliptin, LC 15-0636 and metformin

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

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

Full Information

NCT ID

NCT04070794

First Posted

August 21, 2019

Last Updated

August 25, 2019

Sponsor

LG Chem

1. Study Identification

Unique Protocol Identification Number

NCT04070794

Brief Title

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

Official Title

A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Anticipated)

Primary Completion Date

November 30, 2019 (Anticipated)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FDC Zemimet® SR Tab. 50/1000(Fasting)

Arm Type

Active Comparator

Arm Description

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

Arm Title

FDC Zemimet® SR Tab. 50/1000(Fed)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin

Description

The observed maximum or peak concentration after administration of the drug

Time Frame

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.

Title

AUC0-tlast of gemigliptin, LC 15-0636 and metformin

Description

Area under the concentration-time curve from time zero to the last time where plasma concentration can be measured

Time Frame

Title

AUC0-∞ of gemigliptin, LC 15-0636 and metformin

Description

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

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eunjoo Cho

Phone

+82-2-6987-4284

eunjoo.cho@lgchem.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sirin Khantichaikajon

Phone

+66-2-654-2323

Ext

118

sirink@lgchem.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uthai Suvanakoot

Organizational Affiliation

International Bio Service Co., Ltd.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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