Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of CKD-333 in Healthy Volunteers

NCT04019743 | Completed Phase 1

• 1 other identifier: A70_07BE1906P
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, fasted, single dose, crossover study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

Conditions

Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-330, D086, CKD-333

  Area under the CKD-330/D086/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, D086, CKD-333

  The maximum CKD-330/D086/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 (6)

Group 1

EXPERIMENTAL

1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C

Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

Group 2

EXPERIMENTAL

1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B

Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

Group 3

EXPERIMENTAL

1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A

Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

Group 4

EXPERIMENTAL

1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A

Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

Group 5

EXPERIMENTAL

1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C

Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

Group 6

EXPERIMENTAL

1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B

Drug: CKD-330 16/10mg Tab. 1T and D086 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 1 Tab. 1T; Drug: CKD-333 16/10/40mg formulation 2 Tab. 1T

Interventions

CKD-330 16/10mg Tab. 1T and D086 Tab. 1T DRUG

single oral administration under fasting condition

Also known as: Treatment A

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

CKD-333 16/10/40mg formulation 1 Tab. 1T DRUG

single oral administration under fasting condition

Also known as: Treatment B

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

CKD-333 16/10/40mg formulation 2 Tab. 1T DRUG

single oral administration under fasting condition

Also known as: Treatment C

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

Eligibility Criteria

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

You may qualify if:

• to 55 years old healthy subject at the screening
• Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and a total body weight ≥ 55 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 in accordance with the screening results (laboratory tests, vital signs, ECG etc.)
• 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 drug
• 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 during the study period

You may not qualify if:

• Individuals with a medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or immune disease (excluding simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
• Individuals with a medical history of gastrointestinal disease (e.g., gullet disease including esophageal achalasia, esophagostenosis, or Crohn's disease) or operations (excluding simple appendectomy, herniotomy, or tooth extraction surgery) that may affect drug absorption
• Individuals with the following laboratory test results:
• ALT or AST \> 2x the upper limit of the normal range
• CK \> 3x the upper limit of the normal range
• A 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) of other clinical study or bioequivalence study within the 6 months prior to the first dose of this study
• Individuals with the following vital signs results at screening Individuals who had sitting blood pressure ≥90 mmHg or \<140 mmHg (systolic) or ≥90 mmHg or \<60 mmHg (diastolic)
• Individuals with a medical history of significant alcohol abuse 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 conditions that may increase the risk associated with study participation or investigational product(s) administration, or may interfere with the interpretation of study results
• Individuals with hypersensitivity to ingredients used in the investigational product(s)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: July 11, 2019
• First Posted: July 15, 2019
• Study Start: July 28, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 4, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)