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

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Open-label, Single-dose, Two-way Crossover Bioequivalence Study of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) and Coadministration of Zemiglo Tablet 50 mg (Gemigliptin 50 mg) and Glucophage® XR 1000 mg (Metformin Hydrochloride Prolonged Release 1000 mg) Under Fasting Conditions in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317703
• Other study ID #: LG-DMCL009
• Status: Completed
• Phase: Phase 1
• Start date: August 19, 2020
• Est. completion date: September 5, 2020

Study information

• Verified date: February 2021
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 5, 2020
• Est. primary completion date: September 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• 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.
• 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).

Locations

Country	Name	City	State
Thailand	International Bio Service Co., Ltd.	Nakhon Pathom

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioequivalence study	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	Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 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, 32.00 and 48.00 hours post-dose