Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D086 in Healthy Volunteers Under Fasting Conditions

This study is a randomized, open, single-dose, 3 period partial replicated crossover-design study to investigate the pharmacokinetic profiles and safety of CKD-333 in healthy volunteers.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: CKD-333 Tab.; Drug: CKD-330 Tab. and D086 Tab.

Detailed Description

To healthy subjects of fifty-one (51), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Jang Hee Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 54 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults over the age of 19 years and under the age of 55 years at the time of screening

2. 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

3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
4. 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
5. Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation
6. 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
7. Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria:

1. Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
2. Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption

3. Individuals with the following results at screening test:

   • ALT or AST > 2x the upper limit of the normal range
   • Creatinine > upper limit of the normal range or eGFR with MDRD <60 ml/min/1.73 m2
   • ECG Result, QTc > 450msec
   • CPK > UNL(upper normal limit) x 3.0
   • K > 5.5mEq/l
   • Hct < lower limit of the normal range
4. A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first dose to end of last blooding (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)
5. Individuals who smoked more than 20 cigarettes per day within 6 months prior to screening or cannot quit smoking during hospitalization period
6. 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

7. Following vital signs results at screening

   • Sitting systolic blood pressure ≥ 140 mmHg or < 90 mmHg
   • sitting diastolic blood pressure ≥90 mmHg or <60 mmHg
8. Individuals with a medical history of significant drug abuse within one year prior to the screening or positive for abuse drug in urine test results at screening
9. Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 30days before the first administration of clinical trial drug
10. Individuals who had taken prescription or nonprescription drugs within the 10 days prior to the first dose of investigational product(s)
11. 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)
12. Individuals with hypersensitivity to investigational products or the investigational products ingredients

13. Patients or conditions deemed to be at risk for using investigational products

    • Patient with hyperkalemia
    • Patients with hepatopathy
    • Patients with hereditary angioedema, ACE inhibitors or angiotensin 2 receptor antagonists who have a history of angioedema
    • Primary hyperaldosteronism
    • Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
    • Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
    • Patients with Intravascular volume depletion
    • Patients with diabetes or kidney failure
    • Patients with renal artery stenosis
    • Patients with muscle disease
    • Patients with Hypothyroidism
    • Patients with a history of muscle toxicity when using statins or fibrates
    • Patients who have recently had a kidney transplant
    • Patients with history of shock
14. Individuals with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
15. Individuals who drunk grapefruit juice or caffeine more than 5 cup per day within 3 months prior to screening or cannot quit drinking during clinical trials period
16. Individuals who cannot eat standard meal in institution
17. Women who are pregnant or may be pregnant
18. Individuals who were deemed to be inappropriate to participate in the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Reference-Reference-Test	Drug: CKD-333 Tab.; 1T; Other Names: Test; Drug: CKD-330 Tab. and D086 Tab.; 1T; Other Names: Reference
EXPERIMENTAL: Reference-Test-Reference	Drug: CKD-333 Tab.; 1T; Other Names: Test; Drug: CKD-330 Tab. and D086 Tab.; 1T; Other Names: Reference
EXPERIMENTAL: Test-Reference-Reference	Drug: CKD-333 Tab.; 1T; Other Names: Test; Drug: CKD-330 Tab. and D086 Tab.; 1T; Other Names: Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-330, D086, CKD-333	Area under the CKD-330/D086/CKD-333 concentration in blood-time curve from zero to final	[Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 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	[Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours]

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 14, 2020
• Primary Completion (ANTICIPATED): November 5, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: A70_09BE2005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No