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

NCT ID: NCT04317703

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2020-09-05

Brief Summary

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

Conditions

Type 2 Diabetes

Study Design

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

Study Groups

Test: Gemigliptin/Metformin

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

Group Type: EXPERIMENTAL

Gemigliptin tartrate sesquihydrate and metformin

Intervention Type: DRUG

Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.

Reference: Gemigliptin and Metformin

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

Group Type: ACTIVE_COMPARATOR

gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release

Intervention Type: DRUG

Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.

Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base).

Interventions

Gemigliptin tartrate sesquihydrate and metformin

Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.

Intervention Type: DRUG

gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release

Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.

Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base).

Intervention Type: DRUG

Other Intervention Names

Zemimet® SR Tab. 50/1000 mg; Zemiglo Tablet 50 mg and Glucophage XR 1000 mg

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

• 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

Porrani Puranajoti, Ph.D

Role: PRINCIPAL_INVESTIGATOR

International Bio Service Co., Ltd.

Locations

International Bio Service Co., Ltd.

Nakhon Pathom, , Thailand

Countries

Thailand

Other Identifiers

LG-DMCL009

Identifier Type: -

Identifier Source: org_study_id