Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

Chong Kun Dang Pharmaceutical36 enrolled

Overview

The object of clinical trial is to investigate the pharmacokinetics and safety compared to CKD-333 and co-administration CKD-330, D090 under fasting condition in healthy male adults.

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 D090 in healthy male adults

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Dyslipidemias

Interventions

CKD-333, formula IDRUG

Test drug

CKD-333, formula IIDRUG

Test drug

CKD-330, D090DRUG

Reference Drug

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy male adults aged 19 to 45 years 2. Body weight more than 50kg and within ideal body weight ±20% 3. signed informed consent form 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. Systolic Blood pressure≥140mmHg or Systolic Blood pressure\<90mmHg, Diastolic Blood Pressure≥90mmHg or Diastolic Blood Pressure\<60mmHg

Locations (1)

Seoul Saint Mary's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUClast of Candesartan

Area under the plasma concentration-time curve to last concentration of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

AUClast of Amlodipine

Area under the plasma concentration-time curve to last concentration of Amlodipine

Time frame: 0 hour ~ 72 hour after drug administration

AUClast of Atorvastatin

Area under the plasma concentration-time curve to last concentration of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

Cmax of Candesartan

Maximum plasma concentration of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

Cmax of Amlodipine

Maximum plasma concentration of Amlodipine

Time frame: 0 hour ~ 72 hour after drug administration

Cmax of Atorvastatin

Maximum plasma concentration of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

Secondary Outcomes

AUCinf of Candesartan

Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

AUCinf of Amlodipine

Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine

Central Contacts

Seunghun Han, Ph.D.

CONTACT

+82-2-2258-7326 waystolove@catholic.ac.kr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 0 hour ~ 72 hour after drug administration

AUCinf of Atorvastatin

Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

AUCinf of 2-hydroxy atorvastatin

Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

Tmax of Candesartan

Time to maximum plasma concentration of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

Tmax of Amlodipine

Time to maximum plasma concentration of Amlodipine

Time frame: 0 hour ~ 72 hour after drug administration

Tmax of Atorvastatin

Time to maximum plasma concentration of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

Tmax of 2-hydroxy atorvastatin

Time to maximum plasma concentration of 2-hydroxy atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

T1/2 of Candesartan

Half-life of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

T1/2 of Amlodipine

Half-life of Amlodipine

Time frame: 0 hour ~ 72 hour after drug administration

T1/2 of Atorvastatin

Half-life of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

T1/2 of 2-hydroxy atorvastatin

Half-life of 2-hydroxy atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

clearance of Candesartan

Apparent clearance of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

clearance of Amlodipine

Apparent clearance of Amlodipine

Time frame: 0 hour ~ 72 hour after drug administration

clearance of Atorvastatin

Apparent clearance of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

clearance of 2-hydroxy atorvastatin

Apparent clearance of 2-hydroxy atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

Vd/F of Candesartan

Apparent volume of distribution of Candesartan

Time frame: 0 hour ~ 72 hour after drug administration

Vd/F of Amlodipine

Apparent volume of distribution of Amlodipine

Time frame: 0 hour ~ 72 hour after drug administration

Vd/F of Atorvastatin

Apparent volume of distribution of Atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration

Vd/F of 2-hydroxy atorvastatin

Apparent volume of distribution of 2-hydroxy atorvastatin

Time frame: 0 hour ~ 72 hour after drug administration