Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393

NCT04706286 | Unknown Phase 1

• 1 other identifier: A98_03BE2018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-393 0.5/100/1000 mg under fed condition

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (2)

• AUCt(Area Under Curve last) of CKD-393

  Area under the plasma concentration time curve of CKD-393, from time zero up to the last measurable concentration.

  From predose, upto 48 hours post-dose

• Cmax of CKD-393

  The maximum concentration observed of CKD-393 over blood sampling time.

  From predose, upto 48 hours post-dose

Study Arms (2)

Group 1

EXPERIMENTAL

1. Period 1: Treatment A 2. Period 2: Treatment B

Drug: CKD-501, D759, D150; Drug: CKD-393 0.5/100/1000 mg

Group 2

EXPERIMENTAL

1. Period 1: Treatment B 2. Period 2: Treatment A

Drug: CKD-501, D759, D150; Drug: CKD-393 0.5/100/1000 mg

Interventions

CKD-501, D759, D150 DRUG

CKD-501 0.5 mg 1T, D759 100 mg 1T and D150 1000 mg 1T, single oral administration under fed condition

Also known as: Treatment A

Group 1; Group 2

CKD-393 0.5/100/1000 mg DRUG

CKD-393 0.5/100/1000 mg 1T, single oral administration under fed condition

Also known as: Treatment B

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Healthy adult who is 19 \~ 55 years at the time of screening
• Body weight more than 55 kg for male and more than 50kg for female
• BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
• Females must be menopause or surgical infertility
• Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
• Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.

You may not qualify if:

• Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
• Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Subjects with poor oral intake, susceptible to dehydration or clinically significant dehydration
• Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
• Subjects who have a history of clinically significant hypersensitivity to drugs or additives
• Subjects who have severe infectious disease and severe trauma before and after operation
• Subjects who have undergone i.v. testing of radioactive iodine contrast material within 48 hours before the first IP administration
• Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
• AST, ALT\> UNL(Upper Normal Limit)x1.25
• eGFR (Estimated Glomerular Filtration Rate) \<60 mL/min/1.73m2 using the MDRD (Modification of Diet in Renal Disease) equation
• Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
• After resting for more than 5 minutes, systolic blood pressure\> 150 mmHg or \< 90 mmHg, diastolic blood pressure\> 100 mmHg or \<50 mmHg
• Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
• Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons
• Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, 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

• Choon Ok Kim, M.D., Ph.D.

  Severance hospital of the Yonsei University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Choon Ok Kim, M.D., Ph.D.

CONTACT

+82-2-2228-0455; DELIVERY98@yuhs.ac

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: January 10, 2021
• First Posted: January 12, 2021
• Study Start: February 18, 2021
• Primary Completion: March 29, 2021
• Study Completion: April 5, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)