A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) 80/20/10mg

NCT04987970 | Completed Phase 1

• 1 other identifier: A83_07BE2117
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-386(2)

Conditions

Hypertension and Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-386(2)

  Area under the concentration-time curve from time zero to time

  Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours

• Cmax of CKD-386(2)

  Maximum plasma concentration of the drug

  Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours

Secondary Outcomes (4)

• AUCinf of CKD-386(2)

  Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours

• Tmax of CKD-386(2)

  Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours

• AUCt/AUCinf of CKD-386(2)

  Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72 hours

• T1/2 of CKD-386(2)

  Pre-dose (0 hour), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 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(2)- A single oral dose of 1 tablet under fasting condition Period 3: D013, D326, D337- A single oral dose of 3 tablets under fasting condition Period 4: CKD-386(2)- A single oral dose of 1 tablet under fasting condition

Drug: CKD-386(2); Drug: D013, D326, D337

Sequence 2

EXPERIMENTAL

Period 1: CKD-386(2)- 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(2)- 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(2); Drug: D013, D326, D337

Interventions

CKD-386(2) DRUG

QD, PO

Sequence 1; Sequence 2

D013, D326, D337 DRUG

QD, PO

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 ≥50kg (man) or 45kg (woman), 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 take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
• 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 Kim, M.D., PhD.

  Seoul, Gwanak-gu, 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: July 26, 2021
• First Posted: August 3, 2021
• Study Start: September 12, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 27, 2021
• Last Updated: February 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)