Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-386 in Healthy Volunteers Under Fasting Conditions

NCT05552495 | Completed Phase 1

• 1 other identifier: A83_09BE2219P
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-386 in healthy volunteers under fasting conditions.

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-386

  Area under the CKD-386 concentration in blood-time curve from 0 to t

  0, 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

  The maximum CKD-386 concentration in blood sampling time t

  0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours

Study Arms (6)

Reference-Test1-Test2

EXPERIMENTAL

Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Reference-Test2-Test1

EXPERIMENTAL

Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Test1-Reference-Test2

EXPERIMENTAL

Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Test1-Test2-Reference

EXPERIMENTAL

Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Test2-Reference-Test1

EXPERIMENTAL

Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Test2-Test1-Reference

EXPERIMENTAL

Drug: CKD-386(4) F1; Drug: CKD-386(4) F2; Drug: D013, D326, D337

Interventions

CKD-386(4) F1 DRUG

1 Tablet

Also known as: Test1

Reference-Test1-Test2; Reference-Test2-Test1; Test1-Reference-Test2; Test1-Test2-Reference; Test2-Reference-Test1; Test2-Test1-Reference

CKD-386(4) F2 DRUG

1 Tablet

Also known as: Test2

Reference-Test1-Test2; Reference-Test2-Test1; Test1-Reference-Test2; Test1-Test2-Reference; Test2-Reference-Test1; Test2-Test1-Reference

D013, D326, D337 DRUG

D013 1 Tablet, D326 1Tablet, D337 1 Tablet

Also known as: Reference

Reference-Test1-Test2; Reference-Test2-Test1; Test1-Reference-Test2; Test1-Test2-Reference; Test2-Reference-Test1; Test2-Test1-Reference

Eligibility Criteria

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

You may qualify if:

• Healthy adults volunteers aged ≥19 years
• Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) \< 30 kg/m2 and total body weight ≥ 55 kg BMI = Weight(kg)/ Height(m)2
• Following vital signs results at screening
• Systolic blood pressure: 90 mmHg to 139 mmHg
• Diastolic blood pressure: 60 mmHg to 89 mmHg
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
• Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, serology, urology etc.) and ECG etc. performed
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
• Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective and content

You may not qualify if:

• Individuals who had been administered investigational product(s) from other clinical study or bioequivalence study within the 6 months prior to the first administration of investigational 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)
• Individuals who donated whole blood within the 8 weeks, or blood components within 4 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational drugs
• Individuals who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery
• Individuals who meet the following condition with 1 month of the first administration of investigational drugs
• Alcohol: Man-21 glasses/week, Woman-14 glasses/week (1 glass = soju 50mL or liquor 30mL or beer 250mL)
• 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+ Yangji Hospita

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 Kim, M.D.

  Gwanak-gu, Seoul, South Korea, 08779

  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: September 21, 2022
• First Posted: September 23, 2022
• Study Start: September 23, 2022
• Primary Completion: November 27, 2022
• Study Completion: December 12, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)