Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

NCT04651881 | Unknown Phase 1

• 1 other identifier: A88_09BE2016P
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-385

  Area under the concentration-time curve from time zero to time of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

• Cmax of CKD-385

  Maximum plasma concentration of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Secondary Outcomes (5)

• AUCinf of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

• Tmax of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

• T1/2 of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

• CL/F of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

• Vd/F of CKD-385

  Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours

Study Arms (6)

Group 1

EXPERIMENTAL

1. Period 1: Reference drug 2. Period 2: Test drug 1 3. Period 3: Test drug 2

Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Group 2

EXPERIMENTAL

1. Period 1: Test drug 2 2. Period 2: Reference drug 3. Period 3: Test drug 1

Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Group 3

EXPERIMENTAL

1. Period 1: Test drug 1 2. Period 2: Test drug 2 3. Period 3: Reference drug

Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Group 4

EXPERIMENTAL

1. Period 1: Test drug 2 2. Period 2: Test drug 1 3. Period 3: Reference drug

Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Group 5

EXPERIMENTAL

1. Period 1: Test drug 1 2. Period 2: Reference drug 3. Period 3: Test drug 2

Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Group 6

EXPERIMENTAL

1. Period 1: Reference drug 2. Period 2: Test drug 2 3. Period 3: Test drug 1

Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Interventions

Reference drug DRUG

1 Cap., single oral administration under fed condition

Also known as: D744

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Test drug 1 DRUG

1 Tab., single oral administration under fed condition

Also known as: CKD-385 64 mg formulation I (878mg)

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Test drug 2 DRUG

1 Tab., single oral administration under fed condition

Also known as: CKD-385 64 mg formulation II (878mg)

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

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 more than 19 at the time of screening
• Those who had 18.0kg/m² ≤ Body Mass Index (BMI) \< 30.0kg/m²
• \# BMI=Weight(kg) / Height(m)²
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
• Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
• Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
• Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

You may not qualify if:

• Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
• Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
• Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
• Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
• Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
• Those who have taken any drugs that may affect the clinical trial within 10 days.
• Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
• Those who is unable to consume a high-fat meal provided during the study.
• Those who are deemed insufficient to participate in this clinical study by investigators.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Central Hospital

Gyeonggi-do, Siheung-si, 15079, South Korea

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Min-gi Kim

  CENTRAL HOSPITAL

  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: November 26, 2020
• First Posted: December 3, 2020
• Study Start: October 27, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

KR (1)