A Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetics of CKD-378

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378

Study Overview

• Status: Completed
• Conditions: Type II Diabetes
• Intervention / Treatment: Drug: CKD-378, QD, PO Drug: D745, D150, QD, PO

Detailed Description

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety after Oral Administration of CKD-378 and Co-administration of D745, D150 in Healthy Adults

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult aged between 19 to 55 at screening
2. Weight ≥ 50kg(man) or 50kg(woman)
3. Body mass index (BMI) of 18.5 to 27.0kg/m2
4. If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized.
5. Those who agree to contraception from the first IP dosing day till 28 days after the last dosing day and decide not to provide sperm during the participation of clinical trial
6. Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial

Exclusion Criteria:

1. Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Haemato-oncology disorder, Cardiovascular disorder or Psychical disorder.
2. Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration.
3. Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration.
4. Those who have significant disease or medical history of urinary infection.
5. Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
6. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption.
7. Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin.

8. Those who have tested inappropriate in screening test 28 days prior to IP administration.

   • AST, ALT > 1.5 times higher than upper normal level
   • eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
   • "Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR
   • Under 5 min resting condition, systolic blood pressure >150 mmHg or or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg.
9. Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
10. Woman who are pregnant or breastfeeding
11. Those who exceed an alcohol, caffeine and cigarette consumption (caffeine> 5 cups/day, alcohol> 210g/week, smoking> 10 cigarettes/day) and not able to stop on smoking, caffeine and alcohol

12. Those who have used following drugs that can interfere with the study or have impact on safety of the subject.

    • ETC, herbal medicinal preparations within 14 days before the first dosing date
    • OTC, vitamins, health supplement within 7 days before the first dosing date
    • Depot injection or implantation within 30 days before the first dosing date
13. Those who received investigational products or participated in bioequivalence test within 180 days before the first administration of clinical trial drugs
14. Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days
15. Those who have received blood transfusion in 30 days
16. Those who are deemed insufficient to participate in clinical study by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D745, D150 - A single oral dose of 2 tablets under food intake condition; Period 2: CKD-378 - A single oral dose of 1 tablet under food intake condition	Drug: CKD-378, QD, PO Drug: D745, D150, QD, PO; Durg: CKD-378, QD, PO Drug: D745, D150, QD, PO; Other Names: CKD-378
Experimental: Sequence 2; Period 1: CKD-378 - A single oral dose of 1 tablet under food intake condition; Period 2: D745, D150 - A single oral dose of 2 tablets under food intake condition	Drug: CKD-378, QD, PO Drug: D745, D150, QD, PO; Durg: CKD-378, QD, PO Drug: D745, D150, QD, PO; Other Names: CKD-378

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1. AUCt of CKD-378: Area under the concentration-time curve time zero to time	Pre-dose(0 hour) to 48 hours
2. Cmax of CKD-378: Maximum plasma concentration of the drug	Pre-dose(0 hour) to 48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CKD-378
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A129_01BE2225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No