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

Phase 1

• Conditions: Dyslipidemias; Hypertension
• Interventions: Drug: CKD-333, formula I; Drug: CKD-333, formula II; Drug: CKD-330, D090

• Registration Number: NCT03849287
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

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 D090 in healthy male adults

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-22
• Study Start: 2019-02-25
• Primary Completion: 2019-03-29
• Study Completion: 2019-04-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	CKD-333, formula II	* Period 1: CKD-333, formula I * Period 2: CKD-333, formula II * Period 3: CKD-330, D090
Group 1	CKD-333, formula I	* Period 1: CKD-333, formula I * Period 2: CKD-333, formula II * Period 3: CKD-330, D090
Group 1	CKD-330, D090	* Period 1: CKD-333, formula I * Period 2: CKD-333, formula II * Period 3: CKD-330, D090
Group 2	CKD-333, formula I	* Period 1: CKD-333, formula I * Period 2: CKD-330, D090 * Period 3: CKD-333, formula II
Group 2	CKD-333, formula II	* Period 1: CKD-333, formula I * Period 2: CKD-330, D090 * Period 3: CKD-333, formula II
Group 2	CKD-330, D090	* Period 1: CKD-333, formula I * Period 2: CKD-330, D090 * Period 3: CKD-333, formula II
Group 3	CKD-333, formula I	* Period 1: CKD-333, formula II * Period 2: CKD-330, D090 * Period 3: CKD-333, formula I
Group 3	CKD-333, formula II	* Period 1: CKD-333, formula II * Period 2: CKD-330, D090 * Period 3: CKD-333, formula I
Group 3	CKD-330, D090	* Period 1: CKD-333, formula II * Period 2: CKD-330, D090 * Period 3: CKD-333, formula I
Group 4	CKD-333, formula I	* Period 1: CKD-333, formula II * Period 2: CKD-333, formula I * Period 3: CKD-330, D090
Group 4	CKD-333, formula II	* Period 1: CKD-333, formula II * Period 2: CKD-333, formula I * Period 3: CKD-330, D090
Group 4	CKD-330, D090	* Period 1: CKD-333, formula II * Period 2: CKD-333, formula I * Period 3: CKD-330, D090
Group 5	CKD-333, formula I	* Period 1: CKD-330, D090 * Period 2: CKD-333, formula I * Period 3: CKD-333, formula II
Group 5	CKD-333, formula II	* Period 1: CKD-330, D090 * Period 2: CKD-333, formula I * Period 3: CKD-333, formula II
Group 5	CKD-330, D090	* Period 1: CKD-330, D090 * Period 2: CKD-333, formula I * Period 3: CKD-333, formula II
Group 6	CKD-333, formula I	* Period 1: CKD-330, D090 * Period 2: CKD-333, formula II * Period 3: CKD-333, formula I
Group 6	CKD-333, formula II	* Period 1: CKD-330, D090 * Period 2: CKD-333, formula II * Period 3: CKD-333, formula I
Group 6	CKD-330, D090	* Period 1: CKD-330, D090 * Period 2: CKD-333, formula II * Period 3: CKD-333, formula I

Primary Outcome Measures

Name	Time	Method
AUClast of Candesartan	0 hour ~ 72 hour after drug administration	Area under the plasma concentration-time curve to last concentration of Candesartan
AUClast of Amlodipine	0 hour ~ 72 hour after drug administration	Area under the plasma concentration-time curve to last concentration of Amlodipine
AUClast of Atorvastatin	0 hour ~ 72 hour after drug administration	Area under the plasma concentration-time curve to last concentration of Atorvastatin
Cmax of Amlodipine	0 hour ~ 72 hour after drug administration	Maximum plasma concentration of Amlodipine
Cmax of Candesartan	0 hour ~ 72 hour after drug administration	Maximum plasma concentration of Candesartan
Cmax of Atorvastatin	0 hour ~ 72 hour after drug administration	Maximum plasma concentration of Atorvastatin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul Saint Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of