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

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed); Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)

• Registration Number: NCT05105698
• Lead Sponsor: LG Chem

Brief Summary

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

\[Objectives\]

* 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 Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Study Start: 2022-01-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fed conditions	gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)	B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)
fasting conditions	gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)	A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	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	Cmax will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin
Area under the plasma concentrationup up to the last measurable concentration (AUC0-tlast)	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	AUC0-tlast will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin
Area under the plasma concentration-time curve to from time 0 to infinite(AUC0-∞)	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	AUC0-∞ will be determined from the plasma concentration data of gemigliptin, LC15-0636 and dapagliflozin