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

LG Chem

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed); Drug: gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05105698

LG-GLCL003

Details and patient eligibility

About

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

Full 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

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

fasting conditions

Experimental group

Description:

A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)

Treatment:

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

fed conditions

Experimental group

Description:

B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)

Treatment:

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