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

NCT04070794 | Unknown Phase 1

• 1 other identifier: LG-DMCL008
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (3)

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

  The observed maximum or peak concentration after administration of the drug

  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.

• 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

  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.

• 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

  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.

Study Arms (2)

FDC Zemimet® SR Tab. 50/1000(Fasting)

ACTIVE COMPARATOR

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

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

FDC Zemimet® SR Tab. 50/1000(Fed)

ACTIVE COMPARATOR

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

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

Interventions

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

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

FDC Zemimet® SR Tab. 50/1000(Fed)

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 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
• 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

MeSH Terms

Interventions

LC15-0444

Study Officials

• Uthai Suvanakoot

  International Bio Service Co., Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunjoo Cho

CONTACT

+82-2-6987-4284; eunjoo.cho@lgchem.com

Sirin Khantichaikajon

CONTACT

+66-2-654-2323; sirink@lgchem.com

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: August 21, 2019
• First Posted: August 28, 2019
• Study Start: November 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 30, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share