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

LG Chem28 enrolled

Overview

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

\[Objectives\] * 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)DRUG

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)

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)DRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

eunjoo cho

CONTACT

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

Data from ClinicalTrials.gov

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