NCT06204107

A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 54 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers

Detailed description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	CKD-379(Empagliflozin+sitagliptin+metformin) Test drug	oral, once
DRUG	CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug	oral, once

Timeline

• Start date: 2023-11-21
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2024-01-12
• Last updated: 2024-01-12

Locations

1 site across 1 country: South Korea