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

NCT05698043 | Completed Phase 1

• 1 other identifier: A83_10BE2223
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

* 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); Drug: D013, D326, D337

Sequence 2

EXPERIMENTAL

* 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); Drug: D013, D326, D337

Interventions

CKD-386(5) DRUG

Test

Sequence 1; Sequence 2

D013, D326, D337 DRUG

Reference

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers aged ≥ 19 years
• Weight ≥55kg with calculated body mass index (BMI) of 18 to 30 kg/m2
• Those who meet the blood pressure criteria during screening tests:
• Systolic Blood Pressure: 90 to 139 mmHg
• Diastolic Blood Pressure: 60 to 89 mmHg
• Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
• Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
• Those who agree to contraception during the participation of clinical trial.
• Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

You may not qualify if:

• Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
• 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)
• Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a 4 weeks.
• Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
• 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
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H plus Yangji hospital

Seoul, 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 Officials

• Jaewoo Jaewoo, M.D.

  H Plus Yangji 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: January 16, 2023
• First Posted: January 26, 2023
• Study Start: July 17, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 26, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)