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

NCT04317703 | Completed Phase 1

• 1 other identifier: LG-DMCL009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test: Gemigliptin/Metformin

EXPERIMENTAL

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

Drug: Gemigliptin tartrate sesquihydrate and metformin

Reference: Gemigliptin and Metformin

ACTIVE COMPARATOR

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

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

Interventions

Gemigliptin tartrate sesquihydrate and metformin DRUG

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

Also known as: Zemimet® SR Tab. 50/1000 mg

Test: Gemigliptin/Metformin

gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release 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).

Also known as: Zemiglo Tablet 50 mg and Glucophage XR 1000 mg

Reference: Gemigliptin and Metformin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• lead ECG demonstrating QTc \>450 msec, a QRS interval \>120 msec or with an abnormality considered clinically significant at screening

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

International Bio Service Co., Ltd.

Nakhon Pathom, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; LC15-0444

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Porrani Puranajoti, Ph.D

  International Bio Service Co., Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: August 19, 2020
• Primary Completion: September 5, 2020
• Study Completion: September 5, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)