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

Study Overview
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Brief Summary
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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

Detailed Description
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[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

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)
* Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fasting conditions<br>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)<br>* 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)<br>* Other names: DPP-4 inhibitor and SGLT-2 inhibitor combination;|
| Experimental: fed conditions<br>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)<br>* 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)<br>* Other names: DPP-4 inhibitor and SGLT-2 inhibitor combination;|

What is the study measuring?
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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 |