Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150

NCT05816759 | Completed Phase 1

• 1 other identifier: A101_04BE2113
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D744, and D150 for Healthy Subjects in Fed State

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Cmax of CKD-383

  Cmax: Maximum plasma concentration of the drug

  Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)

• AUCt of CKD-383

  AUCt: Area under the concentration-time curve from time zero to time

  Pre-does(0 hour), Post-dose(0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 hour)

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: CKD-383 (A single oral dose of 1 tablet under fed condition) Period 2: CKD-501, D744, D150 (A single oral dose of 3 tablets under fed condition)

Drug: CKD-383; Drug: CKD-501, D744, D150

Sequence B

EXPERIMENTAL

Period 1: CKD-501, D744, D150 (A single oral dose of 3 tablets under fed condition) Period 2: CKD-383 (A single oral dose of 1 tablet under fed condition)

Drug: CKD-383; Drug: CKD-501, D744, D150

Interventions

CKD-383 DRUG

QD, PO

Sequence A; Sequence B

CKD-501, D744, D150 DRUG

QD, PO

Sequence A; Sequence B

Eligibility Criteria

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

You may qualify if:

• Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
• Healthy adult who aged 19 to 55 years.
• Those who meet the criteria of anthropometric data
• Man: Body weight ≥ 50 kg, Body mass index 18 to 30 kg/m2
• Woman: Body weight ≥ 45 kg, Body mass index 18 to 30 kg/m2

You may not qualify if:

• Those who have medical history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Sitagliptin, Metformin) or additives.
• Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection.
• Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug.
• Those who have Drug abuse (especially sleeping drugs, central analgesics, opiates or psychotropic drugs such as psychotropic drugs) or persons with a history of substance abuse.
• Those who have the test results written below
• AST, ALT \> 2 times higher than upper normal level
• Total bilirubin \> 2 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 \>160 mmHg or \<90 mmHg, diastolic blood pressure \>100 mmHg or \<50 mmHg
• Those who have determined that the abnormal results are clinically significant in the screening test items (question, vital signs, electrocardiogram, physical test, blood, urine test, etc.).
• Those who participated in other clinical trials within 180 days of the intended study drug administration and have been administered clinical trial medications (except for those who have not taken the study medication).
• Those who has taken a drug (Ethical drug, over the counter drug, herbal medicine, or nutritional supplement (vitamin, etc.)) within 14 days prior to screening (however, if it is considered that it does not affect the safety and research results of the subject, as determined by the investigator).
• Those who donated whole blood within 8 weeks prior to screening, or who donated or donated components (plasma, platelets) within 4 weeks, and consented to prohibit blood donation from 30 days after the last administration of investigational product.
• Those who have continuously consumed more than 21 units/week (1 unit of alcohol = 10 g = 12.5 mL) within 6 months prior to screening.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

CHA Bundang Medical Center, CHA University

Seongnam-si, Bundang, 13497, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

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

Study Officials

• Anhye Kim, Ph.D

  CHA University

  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: April 5, 2023
• First Posted: April 18, 2023
• Study Start: May 26, 2023
• Primary Completion: June 4, 2023
• Study Completion: June 22, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

KR (1)