Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-333 Low Dose in Healthy Volunteers

NCT04611932 | Unknown Phase 1

• 1 other identifier: A70_08BE1907
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, single dose, 3-period partial replicated crossover study to evaluate the pharmacokinetic profiles and safety of CKD-333 low dose in healthy volunteers under fasting conditions.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-330, D090, CKD-333

  Area under the CKD-330/D090/CKD-333 concentration in blood-time curve from zero to final

  Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

• Cmax of CKD-330, D090, CKD-333

  The maximum CKD-330/D090/CKD-333 concentration in blood sampling time t

  Pre-dose (0 hour), post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours

Study Arms (3)

Reference-Reference-Test

EXPERIMENTAL

Drug: CKD-330 Tab. and D090 Tab.; Drug: CKD-333 Tab.

Reference-Test-Reference

EXPERIMENTAL

Drug: CKD-330 Tab. and D090 Tab.; Drug: CKD-333 Tab.

Test-Reference-Reference

EXPERIMENTAL

Drug: CKD-330 Tab. and D090 Tab.; Drug: CKD-333 Tab.

Interventions

CKD-330 Tab. and D090 Tab. DRUG

1T

Also known as: Reference

Reference-Reference-Test; Reference-Test-Reference; Test-Reference-Reference

CKD-333 Tab. DRUG

1T

Also known as: Test

Reference-Reference-Test; Reference-Test-Reference; Test-Reference-Reference

Eligibility Criteria

• Age: 19 Years - 54 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 55 years at the time of screening
• Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg
• \* BMI = Weight(kg)/ Height(m)2
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
• Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial, etc.) and vital signs, ECG etc. performed at screening
• Individuals who signed an informed consent form approved by the 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 product
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
• Individuals with the ability and willingness to participate the entire study period

You may not qualify if:

• Individuals 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 diseases.
• Individuals 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
• Individuals with the following laboratory test results at screening:
• ALT or AST \> 2x the upper limit of the normal range
• CK \> 3x the upper limit of the normal range
• History of regular alcohol consumption exceeding 210 g/week within the 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)
• Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening
• Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
• Following vital signs results at screening
• \- Sitting systolic blood pressure ≥ 140 mmHg or \< 90 mmHg and/or sitting diastolic blood pressure ≥90 mmHg or \<60 mmHg
• Individuals with a medical history of significant alcohol or drug abuse within one year prior to the screening
• Individuals 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)
• Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
• Individuals who donated whole blood within the 2 months, or blood components within 1 month prior to the first dose of the investigational product(s)
• Individuals with severe acute/chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Min-Gul Kim, Professor

CONTACT

+82-63-259-3480; mgkim@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: October 27, 2020
• First Posted: November 2, 2020
• Study Start: November 11, 2020
• Primary Completion: March 10, 2021
• Study Completion: April 27, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)