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

NCT05741437 | Completed Phase 1

• 1 other identifier: A129_01BE2225
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type II Diabetes

Keywords

CKD-378

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

* 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

Sequence 2

EXPERIMENTAL

* 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

Interventions

CKD-378, QD, PO Drug: D745, D150, QD, PO DRUG

Durg: CKD-378, QD, PO Drug: D745, D150, QD, PO

Also known as: CKD-378

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged between 19 to 55 at screening
• Weight ≥ 50kg(man) or 50kg(woman)
• Body mass index (BMI) of 18.5 to 27.0kg/m2
• If female, one of following conditions. Menopause (no menstruation more than 2 years) or surgically sterilized.
• 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
• 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

You may not qualify if:

• 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.
• Those who are vulnerable to dehydration due to lack of ability in oral intake or have dehydration.
• Those who had medical examination requiring radioactive iodine contrast material injected through IV 48 hours prior to first IP administration.
• Those who have significant disease or medical history of urinary infection.
• Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption.
• Those who have hypersensitivity to the main constituents or components of the investigational drug such as empagliflozin, metformin.
• 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.
• Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
• Woman who are pregnant or breastfeeding
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, 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 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: February 14, 2023
• First Posted: February 23, 2023
• Study Start: April 11, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 5, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)