Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg

Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers

A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting); Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)

Detailed Description

[Objectives]

• Primary: To investigate the food-effect bioavailability of absorption of gemigliptin and dapagliflozin 50/10 mg fixed dose combination film-coated tablet in healthy subjects under fed and fasting conditions
• Secondary: To evaluate safety of investigational product under fed and fasting conditions

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/m2. All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.

Exclusion Criteria:

• History serious hypersensitivity reactions
• History or evidence of clinically significant renal, hepatic, gastrointestinal
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
• History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period
• History or evidence of family diabetes
• History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
• etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fasting conditions; A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)	Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting); Subjects will check-in 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.(fasting); Other Names: DPP-4 inhibitor and SGLT-2 inhibitor combination
Experimental: fed conditions; B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)	Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed); Subjects will check-in 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.(fed); Other Names: DPP-4 inhibitor and SGLT-2 inhibitor combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin	Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
Area under the plasma concentrationup up to the last measurable concentration (AUC0-tlast)	AUC0-tlast will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin	Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
Area under the plasma concentration-time curve to from time 0 to infinite(AUC0-∞)	AUC0-∞ will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin	Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors
• Other Study ID Numbers: LG-GLCL003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No