Pharmacokinetics and Safety Profile of CKD-333

An Open-label, Randomized, Fasted, Single-dose, Three-way Crossover Study to Compare the Pharmacokinetics and Safety Between Administration of CKD-333 and Coadministration of CKD-330 and D086 in Healthy Male Adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03659149

Enrollment

Registered

2018-09-06

Start date

2018-08-08

Completion date

2018-10-12

Last updated

2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Hypertension

Keywords

Hypertension, Dyslipidemias, CKD-333

Brief summary

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

Detailed description

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

Interventions

DRUGCKD-333 formulation I

1 tablet administered before the breakfast(single-dose)

DRUGCKD-333 formulation II

1 tablet administered before the breakfast(single-dose)

DRUGCKD-330+D086

2 tablet administered before the breakfast(single-dose)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUCt(Area under the plasma drug concentration-time curve) PK of Candesartan, Amlodipine, Atorvastatin	0~72hours
Cmax(Maximum plasma concentration of the drug in plasma) of Candesartan, Amlodipine, Atorvastatin	0~72hours

Secondary

Measure	Time frame
t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours
AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours
Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours
CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours
Tmax(Time to reach the maximum concentration) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026