A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

Chong Kun Dang Pharmaceutical30 enrolled

Overview

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Dyslipidemias

Interventions

CKD-348 F1DRUG

QD, PO

CKD-348 F2DRUG

QD, PO

CKD-828, D097, D337DRUG

QD, PO

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy adult volunteers aged ≥ 19-year-old 2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2 3. Those who are eligible for adequate 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 chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests 6. Those who agree to contraception during the participation of clinical trial 7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial Exclusion Criteria: 1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug 2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug 3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month 4. Those who has a history of gastrointestinal surgery ( 5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day 6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency 7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption 8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests 9. Women who are pregnant or who may be pregnant and breastfeed

Locations (1)

H Plus Yangji Hospital

Seoul, Gwanak-gu, South Korea