Pharmacokinetics and Safety Profile of CKD-333

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659149
• Other study ID #: 170PK18015
• Status: Completed
• Phase: Phase 1
• Start date: August 8, 2018
• Est. completion date: October 12, 2018

Study information

• Verified date: August 2018
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 12, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• CKD-333 formulation I
1 tablet administered before the breakfast(single-dose)
• CKD-333 formulation II
1 tablet administered before the breakfast(single-dose)
• CKD-330+D086
2 tablet administered before the breakfast(single-dose)

Locations

Country	Name	City	State
Korea, Republic of	Seoul Saint Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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