A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(5) 80/20/10mg

An Open Label, Randomized, Single Dose, 2-sequence, 4-period, Cross-over Clinical Trial to Evaluate the Pharmacokinetics and the Tolerability of CKD-386(5) With Co-administration of D013, D326, and D337 in Healthy Adult Volunteers

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(5)

Study Overview

• Status: Completed
• Conditions: Hypertension and Dyslipidemia
• Intervention / Treatment: Drug: CKD-386(5); Drug: D013, D326, D337

Detailed Description

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and the tolerability of CKD-386(5) with co-administration of D013, D326, and D337 in healthy adult volunteers

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jaewoo Kim, M.D.; Phone Number: +82-70-4665-9193; Email: m3116@newyjh.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • H plus Yangji Hospital
    • Contact: Jaewoo Kim, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2

3. Those who meet the blood pressure criteria during screening tests:

   • Systolic Blood Pressure: 90 to 139 mmHg
   • Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing date, or who have used drugs that may interfere with this study within 10 days before the first dosing day (However, clinical investigational drugs) Participation is possible in consideration of pharmacokinetic and pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs)
3. Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a 4 weeks.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.

5. Those who exceed an alcohol and cigarette consumption than below criteria

   • Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
   • Heavy Smoking: 20 cigarettes/day

6. Patients with the following diseases

   • Patients with hypersensitivity to the main constituents or components of the investigational drug
   • Severe hepatic impairment, biliary atresia or cholestasis
   • Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
   • Diabetes mellitus
   • Patients with moderate to severe renal impairment [glomerular filtration rate (eGFR) <60 mL / min / 1.73m^2]
   • Renal vascular hypertension patients
   • Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
   • Patients with myopathy or have a history of family or genetic history of myopathy
   • Hypothyroidism
   • If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D013, D326, D337- A single oral dose of 3 tablets under fasting condition; Period 2: CKD-386(5)- A single oral dose of 1 tablet under fasting condition; Period 3: D013, D326, D337- A single oral dose of 3tablets under fasting condition; Period 4: CKD-386(5)- A single oral dose of 1 tablet under fasting condition	Drug: CKD-386(5); Test; Drug: D013, D326, D337; Reference
Experimental: Sequence 2; Period 1: CKD-386(5)- A single oral dose of 1 tablet under fasting condition; Period 2: D013, D326, D337- A single oral dose of 3 tablets under fasting condition; Period 3: CKD-386(5)- A single oral dose of 1 tablet under fasting condition; Period 4: D013, D326, D337- A single oral dose of 3 tablets under fasting condition	Drug: CKD-386(5); Test; Drug: D013, D326, D337; Reference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-386(5)	Area under the concentration-time curve from time zero to time	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours
Cmax of CKD-386(5)	Maximum plasma concentration of the drug	Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Jaewoo Jaewoo, M.D., H plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: A83_10BE2223

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