NCT06483243

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.

A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Detailed description

Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG	At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.

Timeline

• Start date: 2024-04-04
• Primary completion: 2024-04-29
• Completion: 2024-05-17
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: South Korea