Pharmacokinetics and Safety Profile of CKD-333

Phase 1

Completed

• Conditions: Hypertension; Dyslipidemias
• Interventions: Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

• Registration Number: NCT03659149
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Study Timeline

• Status Verified: 2018-08
• Study Start: 2018-08-08
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-06
• Primary Completion: 2018-10-05
• Study Completion: 2018-10-12
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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%

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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. SBP(Systolic Blood pressure)≥140mmHg or SBP<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP<60mmHg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	CKD-333 formulation I	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
Group 1	CKD-333 formulation II	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
Group 1	CKD-330+D086	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Test drug 2(CKD-333 formulation II) Period 3: Reference drug(CKD-330 + D086)
Group 2	CKD-333 formulation I	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
Group 2	CKD-333 formulation II	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
Group 2	CKD-330+D086	Period 1: Test drug 1(CKD-333 formulation I) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 2(CKD-333 formulation II)
Group 3	CKD-333 formulation I	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
Group 3	CKD-333 formulation II	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
Group 3	CKD-330+D086	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Reference drug(CKD-330 + D086) Period 3: Test drug 1(CKD-333 formulation I)
Group 4	CKD-333 formulation I	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
Group 4	CKD-333 formulation II	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
Group 4	CKD-330+D086	Period 1: Test drug 2(CKD-333 formulation II) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Reference drug(CKD-330 + D086)
Group 5	CKD-333 formulation I	Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
Group 5	CKD-333 formulation II	Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
Group 5	CKD-330+D086	Period 1: Reference drug(CKD-330 + D086) Period 2: Test drug 1(CKD-333 formulation I) Period 3: Test drug 2(CKD-333 formulation II)
Group 6	CKD-333 formulation I	Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)
Group 6	CKD-333 formulation II	Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)
Group 6	CKD-330+D086	Period 1: Reference drug(CKD-330 + D086) Period 2: Test durg 2(CKD-333 formulation II) Period 3: Test drug 1(CKD-333 formulation I)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Tmax(Time to reach the maximum concentration) 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
t1/2(Time for Cmax to drop in half) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours
CL/F(Apparent clearance) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours
Vd/F(Apparent volume of distribution) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin	0~72hours

Trial Locations

Locations (1)

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