Pharmacokinetics and Safety Profile of CKD-333

NCT03659149 | Completed Phase 1

• 1 other identifier: 170PK18015
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Dyslipidemias

Keywords

Hypertension; Dyslipidemias; CKD-333

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• AUCinf(Area under the plasma concentration-time curve from time t to infinity) of Candesartan, Amlodipine, Atorvastatin, 2-hydroxy-atorvastatin

  0~72hours

• Tmax(Time to reach the maximum concentration) 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

Study Arms (6)

Group 1

EXPERIMENTAL

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)

Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

Group 2

EXPERIMENTAL

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)

Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

Group 3

EXPERIMENTAL

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)

Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

Group 4

EXPERIMENTAL

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)

Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

Group 5

EXPERIMENTAL

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)

Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

Group 6

EXPERIMENTAL

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)

Drug: CKD-333 formulation I; Drug: CKD-333 formulation II; Drug: CKD-330+D086

Interventions

CKD-333 formulation I DRUG

1 tablet administered before the breakfast(single-dose)

Also known as: Test drug

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

CKD-333 formulation II DRUG

1 tablet administered before the breakfast(single-dose)

Also known as: Test drug

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

CKD-330+D086 DRUG

2 tablet administered before the breakfast(single-dose)

Also known as: Reference drug

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 19 aged and 45 aged in healthy male adult
• Body weight more than 50kg and within ideal body weight ±20%

You may not qualify if:

• Have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness
• Have a gastrointestinal disease history that can effect drug absorption or surgery
• SBP(Systolic Blood pressure)≥140mmHg or SBP\<90mmHg, DBP(Diastolic Blood Pressure(≥90mmHg or DBP\<60mmHg

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul Saint Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Seunghun Han, Ph.D.

  Department of Clinical Pharmacology, Seoul ST.Mayr's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: August 8, 2018
• Primary Completion: October 5, 2018
• Study Completion: October 12, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)