Compare the Pharmacokinetics and Safety of CKD-391

NCT04354987 | Completed Phase 1

• 1 other identifier: 152BE18037
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

phase I clinical trial to compare the pharmacokinetics and safety of CKD-391 with co-administration of D090 and D337 in healthy adult volunteers

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

• Cmax

  To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax 1\) Atorvastatin, unconjugated ezetimibe(Cmax)

  0~72hours

• AUCt

  To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt 1\) Atorvastatin, unconjugated ezetimibe(AUCt)

  0~72hours

Study Arms (4)

Group A

EXPERIMENTAL

R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T

Drug: CKD-391 10/10mg; Drug: D090, D337

Group B

EXPERIMENTAL

R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T

Drug: CKD-391 10/10mg; Drug: D090, D337

Group C

EXPERIMENTAL

T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R

Drug: CKD-391 10/10mg; Drug: D090, D337

Group D

EXPERIMENTAL

T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R

Drug: CKD-391 10/10mg; Drug: D090, D337

Interventions

CKD-391 10/10mg DRUG

Drug T: CKD-391 10/10mg(Other Name: Test Drug)

Also known as: Test Drug (T)

Group A; Group B; Group C; Group D

D090, D337 DRUG

D090 and D337 co-administration(Other Name: Reference drug)

Also known as: Reference Drug (R)

Group A; Group B; Group C; Group D

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
• Subjects in good health as determined by physical exams and medical examinations. No congenital or chronic diseases and no abnormal signs determined by medical examinations.
• Not abnormal or not clinically significant lab values.
• Subjects who signed informed consent form with good understandings after explanations by investigators.

You may not qualify if:

• No history or presence of clinically significant diseases.
• Subjects showing adverse reaction to investigational product
• Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
• History of myopathy
• unable to stop drinking and smoking during clinical trials
• Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
• History of drug abuse
• Disagree to contraception
• Subjects who are in any conditions impossible participating in the clinical trials

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Jae-Yong Chung

Gyeonggi-do, Seongnam-si, 463-707, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

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: April 14, 2020
• First Posted: April 21, 2020
• Study Start: October 30, 2019
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

KR (1)