Status:

COMPLETED

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

Lead Sponsor:

Chong Kun Dang Pharmaceutical

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

19-65 years

Phase:

PHASE1

Brief 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-administ...

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)

Eligibility Criteria

Inclusion

  • Healthy adults aged 19 to 65 years
  • Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
  • within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
  • Other inclusion criteria, as defined in the protocol

Exclusion

  • who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period 1 administration)
  • Other exclusive criteria, as defined in the protocol

Key Trial Info

Start Date :

April 4 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 17 2024

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT06483243

Start Date

April 4 2024

End Date

May 17 2024

Last Update

July 3 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, South Korea