NCT05741437

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

February 14, 2023

Last Update Submit

March 8, 2024

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, PODRUG

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

Also known as: CKD-378
Sequence 1Sequence 2

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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)