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

NCT ID: NCT06483243

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2024-05-17

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-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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

• Phase 1: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)
• Phase 2: CKD-383 2 tablets(Test)

Group Type: EXPERIMENTAL

Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Intervention Type: DRUG

At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.

Group B

• Phase 1: CKD-383 2 tablets(Test)
• Phase 2: CKD-501 1 tablet, D745 1 tablet, D150 2 tablets(Reference)

Group Type: EXPERIMENTAL

Test: CKD-383, Reference1: Duvie Tab. 0.5mg, Reference2: Jardiance tablets 25 mg, Reference3: GLUCOPHAGE XR TAB. 1000MG

Intervention Type: DRUG

At around 8 a.m., take Test drug or Reference drug 1,2,3(oral) with 200 mL of water at room temperature.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Test: CKD-383, Reference1: CKD-501, Reference2: D745, Reference3: D150

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun Hwan Oh, PI

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Gwangmyeong Hospital

Locations

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, , South Korea

Countries

South Korea

Other Identifiers

A101_05BE2315

Identifier Type: -

Identifier Source: org_study_id