Pharmacokinetics and Safety Profile of CKD-333

Chong Kun Dang Pharmaceutical37 enrolled

Overview

Compare the pharmacokinetic characteristics and safety between CKD-333 tablet and CKD-330, D086 combination

An open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of CKD-333 and coadministration of CKD-330 and D086 in healthy male adults

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Dyslipidemias

Interventions

CKD-333 formulation IDRUG

1 tablet administered before the breakfast(single-dose)

CKD-333 formulation IIDRUG

1 tablet administered before the breakfast(single-dose)

CKD-330+D086DRUG

2 tablet administered before the breakfast(single-dose)

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Between 19 aged and 45 aged in healthy male adult 2. Body weight more than 50kg and within ideal body weight ±20% Exclusion Criteria: 1. Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness 2. Have a gastrointestinal disease history that can effect drug absorption or surgery 3. SBP(Systolic Blood pressure)≥140mmHg or SBP\<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP\<60mmHg

Locations (1)

Seoul Saint Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin

Time frame: 0~72hours

Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin

Time frame: 0~72hours

Secondary Outcomes

AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

Time frame: 0~72hours

Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

Time frame: 0~72hours

t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

Time frame: 0~72hours

CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

Time frame: 0~72hours

Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

Time frame: 0~72hours

Data from ClinicalTrials.gov

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