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

NCT06483243 | Completed Phase 1

• 1 other identifier: A101_05BE2315
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCt of Lobeglitazone, Empagliflozin, Metformin

  Pharmacokinetic characterization

  0 hour ~ 48 hour after drug administration

• Cmax of Lobeglitazone, Empagliflozin, Metformin

  Pharmacokinetic characterization

  0 hour ~ 48 hour after drug administration

Secondary Outcomes (5)

• AUC∞ of Lobeglitazone, Empagliflozin, Metformin

  0 hour ~ 48 hour after drug administration

• Tmax of Lobeglitazone, Empagliflozin, Metformin

  0 hour ~ 48 hour after drug administration

• T1/2 of Lobeglitazone, Empagliflozin, Metformin

  0 hour ~ 48 hour after drug administration

• CL/F of Lobeglitazone, Empagliflozin, Metformin

  0 hour ~ 48 hour after drug administration

• Vd/F of Lobeglitazone, Empagliflozin, Metformin

  0 hour ~ 48 hour after drug administration

Study Arms (2)

Group A

EXPERIMENTAL

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

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

Group B

EXPERIMENTAL

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

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

Interventions

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

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

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

Group A; Group B

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chung-Ang University Gwangmyeong Hospital

Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yun Hwan Oh, PI

  Chung-Ang University Gwangmyeong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 3, 2024
• Study Start: April 4, 2024
• Primary Completion: April 29, 2024
• Study Completion: May 17, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)