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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03849287
• Other study ID #: 170PK18039
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 25, 2019
• Est. completion date: April 6, 2019

Study information

• Verified date: February 2019
• Source: Chong Kun Dang Pharmaceutical
• Contact: Seunghun Han, Ph.D.
• Phone: +82-2-2258-7326
• Email: waystolove[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 D090 in healthy male adults

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: April 6, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension

Intervention

Drug:
• CKD-333, formula I
Test drug
• CKD-333, formula II
Test drug
• CKD-330, D090
Reference Drug

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	AUClast of Candesartan	Area under the plasma concentration-time curve to last concentration of Candesartan	0 hour ~ 72 hour after drug administration
Primary	AUClast of Amlodipine	Area under the plasma concentration-time curve to last concentration of Amlodipine	0 hour ~ 72 hour after drug administration
Primary	AUClast of Atorvastatin	Area under the plasma concentration-time curve to last concentration of Atorvastatin	0 hour ~ 72 hour after drug administration
Primary	Cmax of Candesartan	Maximum plasma concentration of Candesartan	0 hour ~ 72 hour after drug administration
Primary	Cmax of Amlodipine	Maximum plasma concentration of Amlodipine	0 hour ~ 72 hour after drug administration
Primary	Cmax of Atorvastatin	Maximum plasma concentration of Atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	AUCinf of Candesartan	Area under the plasma concentration-time curve from zero to infinity concentration of Candesartan	0 hour ~ 72 hour after drug administration
Secondary	AUCinf of Amlodipine	Area under the plasma concentration-time curve from zero to infinity concentration of Amlodipine	0 hour ~ 72 hour after drug administration
Secondary	AUCinf of Atorvastatin	Area under the plasma concentration-time curve from zero to infinity concentration of Atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	AUCinf of 2-hydroxy atorvastatin	Area under the plasma concentration-time curve from zero to infinity concentration of 2-hydroxy atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	Tmax of Candesartan	Time to maximum plasma concentration of Candesartan	0 hour ~ 72 hour after drug administration
Secondary	Tmax of Amlodipine	Time to maximum plasma concentration of Amlodipine	0 hour ~ 72 hour after drug administration
Secondary	Tmax of Atorvastatin	Time to maximum plasma concentration of Atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	Tmax of 2-hydroxy atorvastatin	Time to maximum plasma concentration of 2-hydroxy atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	T1/2 of Candesartan	Half-life of Candesartan	0 hour ~ 72 hour after drug administration
Secondary	T1/2 of Amlodipine	Half-life of Amlodipine	0 hour ~ 72 hour after drug administration
Secondary	T1/2 of Atorvastatin	Half-life of Atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	T1/2 of 2-hydroxy atorvastatin	Half-life of 2-hydroxy atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	clearance of Candesartan	Apparent clearance of Candesartan	0 hour ~ 72 hour after drug administration
Secondary	clearance of Amlodipine	Apparent clearance of Amlodipine	0 hour ~ 72 hour after drug administration
Secondary	clearance of Atorvastatin	Apparent clearance of Atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	clearance of 2-hydroxy atorvastatin	Apparent clearance of 2-hydroxy atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	Vd/F of Candesartan	Apparent volume of distribution of Candesartan	0 hour ~ 72 hour after drug administration
Secondary	Vd/F of Amlodipine	Apparent volume of distribution of Amlodipine	0 hour ~ 72 hour after drug administration
Secondary	Vd/F of Atorvastatin	Apparent volume of distribution of Atorvastatin	0 hour ~ 72 hour after drug administration
Secondary	Vd/F of 2-hydroxy atorvastatin	Apparent volume of distribution of 2-hydroxy atorvastatin	0 hour ~ 72 hour after drug administration