Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389

NCT04322032 | Unknown Phase 1

• 1 other identifier: A102_02BE2003
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-389 in healthy volunteers.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCt(Area Under Curve last)

  Area under the plasma concentration time curve of CKD-389/D759\&D308, from time zero up to the last measurable concentration.

  Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h

• Cmax

  The maximum concentration observed of CKD-389/D759\&D308 over blood sampling time.

  Each period: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h

Study Arms (2)

Group 1

EXPERIMENTAL

1. Period 1: Reference drug 2. Period 2: Test drug

Drug: Reference drug; Drug: Test drug

Group 2

EXPERIMENTAL

1. Period 1: Test drug 2. Period 2: Reference drug

Drug: Reference drug; Drug: Test drug

Interventions

Reference drug DRUG

D759 Tab. 1 Tab. and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.

Also known as: D759 and D308

Group 1; Group 2

Test drug DRUG

CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.

Also known as: CKD-389

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Healthy adults over the age of 19 years and under the age of 65 years at the time of screening
• Subject who had 17.5kg/m² ≤ Body Mass Index (BMI) \< 30.5kg/m² and a total body weight of males ≥ 55 kg and females ≥ 45 kg
• \# BMI=Weight(kg) / Height(m)²
• Subject without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
• Subject who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
• Subject who signed an informed consent form approved by the Institutional Review Board(IRB) of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational drug
• Subject who consents to the use of reliable contraception during the clinical trial and not to donate his sperm during the study period and until 1 month after the last administration of investigational product
• Subject with the ability and willingness to participate during the study period

You may not qualify if:

• Subjects with a medical evidence or a history (excluding a dental history of periodontal surgery, impacted wisdom teeth removal, etc.) of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease
• Subjects with a medical history of gastrointestinal disease (e.g., gullet disease such as esophageal achalasia and esophagostenosis and Crohn's disease) or operations (excluding simple appendectomy, herniotomy or tooth extraction) that may affect drug absorption
• Subjects with the following laboratory test result:
• ☞ ALT or AST \> 2x the upper limit of the normal range
• History of regular alcohol consumption exceeding 210 g/week within 6 months prior to screening (1 drink (250 mL) of beer (5%) = 10 g; 1 drink (50 mL) of hard liquor (20%) = 8 g; 1 drink (125 mL) of wine (12%) = 12 g)
• Subjects who smoked more than 20 cigarettes per day within 6 months prior to screening
• Subjects who had been administered investigational product(s) from other clinical study or bioequivalence study within 6 months prior to the first dose of this study
• Following vital signs at screening
• ☞ Sitting systolic blood pressure ≥160 mmHg or \<90 mmHg and/or a sitting diastolic blood pressure ≥100 mmHg or \<50 mmHg at screening
• Subjects with a medical history of significant alcohol or drug abuse within one year prior to the screening
• Subjects who had taken any drug(s) known as a strong inducer(s) or inhibitor(s) of drug-metabolizing enzymes within 30 days prior to the first dose of investigational product(s)
• Subjects who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product(s)
• Subjects who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product(s)
• Subjects with a severe acute/chronic physical and mental conditions that can increase risk or interfere with the interpretation of the results of test
• Subjects who had Type 1 diabetes or diabetic ketoacidosis

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Min-gul Kim

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-gul Kim

CONTACT

+82-63-259-3480; mgkim@jbcp.kr

Kyung-Ho Jang

CONTACT

khjang@jbcp.kr

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: March 24, 2020
• First Posted: March 26, 2020
• Study Start: April 6, 2020
• Primary Completion: May 12, 2020
• Study Completion: May 18, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)