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

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Chem
• Treatments: Dapagliflozin; Dipeptidyl-Peptidase IV Inhibitors; Sodium-Glucose Transporter 2 Inhibitors

Criteria

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.