A Clinical Trial to Evaluate the Food Effect of CKD-378

NCT06386328 | Completed Phase 1

• 1 other identifier: A129_03FDI2317
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to evaluate the food effect of CKD-378

Conditions

Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-378

  Area under the concentration-time curve time zero to time

  Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours

• Cmax of CKD-378

  Maximum plasma concentration of the drug

  Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

* Period 1: A single oral dose of 2 tablets(CKD-378) under fasting condition * Period 2: A single oral dose of 2 tablets(CKD-378) under fed condition

Drug: CKD-378, QD, PO

Sequence 2

EXPERIMENTAL

* Period 1: A single oral dose of 2 tablets(CKD-378) under fed condition * Period 2: A single oral dose of 2 tablets(CKD-378) under fasting condition

Drug: CKD-378, QD, PO

Interventions

CKD-378, QD, PO DRUG

CKD-378, QD, PO

Sequence 1; Sequence 2

Eligibility Criteria

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

You may qualify if:

• Healthy adult aged ≥ 19 at screening
• Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
• Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
• A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, serological tests, urinalysis, etc.), electrocardiogram examination, etc.
• A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
• A person who has agreed to use appropriate contraception and not donate sperm or eggs until 1 week after the first administration of the drug and the last administration of the drug

You may not qualify if:

• Those who have taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of investigational product, or who have taken drug that may interfere with this investigational product within 10 days
• Those with a history of regular alcohol intake before the first administration of investigational product
• More than 21 drinks/week for men
• More than 14 drinks/week for women
• Those who have taken other investigational product within 6 months before the first administration of the investigational product
• Those who have donated whole blood within 8 weeks or donated component blood within 2 weeks or received blood transfusion within 4 weeks before the first administration of the investigational product
• Those with a history of gastrointestinal diseases or surgery (except simple appendicectomy, hernia surgery) that may affect drug absorption ruler
• Those who have following diseases
• Patients with hypersensitivity to the ingredient of an investigational drug or to biguanide drugs
• Patients with moderate and severe renal impairment, end-stage renal disease or dialysis
• Patients with acute conditions that may affect renal function
• Patients with acute or chronic metabolic acidosis and patients with a history of ketoacidosis
• Diabetic precoma patient
• Patients with acute and unstable heart failure
• Patients receiving tests using intravenous radioactive iodine contrast material

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Gimpo Woori hospital

Gimpo-si, Gyeonggi-do, 10099, 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: April 23, 2024
• First Posted: April 26, 2024
• Study Start: May 3, 2024
• Primary Completion: June 3, 2024
• Study Completion: June 13, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)