NCT06492655

To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers

A Randomized, Open-label, Single Dose, Crossover, Phase 1 Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-383 in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• 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 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers

Detailed description

Participants were randomly assigned in a 1:1 ratio. TheParticipants 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-383(Fed)	After maintaining NPO for at least 10 hours before a high-fat meal, take a high-fat meal within 20 minutes on each medication day, and take CKD-383 two tablets orally with 150 mL of water at room temperature.
DRUG	CKD-383(Fasted)	After maintaining NPO for at least 10 hours before dosing, and take CKD-383 two tablets orally with 150 mL of room temperature water with 30g of sugar added on each dosing day.

Timeline

• Start date: 2024-07-04
• Primary completion: 2024-08-01
• Completion: 2024-08-08
• First posted: 2024-07-09
• Last updated: 2024-07-10