Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337

NCT03793985 | Completed Phase 1

• 1 other identifier: 152BE17006
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the pharmacokinetic characteristics and safety between CKD-391 tablet and D337, D337 combination

Conditions

Hyperlipidemias

Outcome Measures

Primary Outcomes (2)

• Cmax

  To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax

  0~72hours

• AUCt

  To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt

  0~72hours

Study Arms (2)

A (R+T+R+T)

EXPERIMENTAL

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

Drug: T; Drug: R

B (T+R+T+R)

ACTIVE COMPARATOR

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

Drug: T; Drug: R

Interventions

T DRUG

CKD-391 40/10mg

Also known as: Test Drug

A (R+T+R+T); B (T+R+T+R)

R DRUG

D086 and D337 co-administration

Also known as: Reference drug

A (R+T+R+T); B (T+R+T+R)

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
• Over 50 kg, BMI between 18.0-29.0 kg/m2
• 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
• Subjects with abnormal lab values at least one below 1) AST or ALT\>2 fold of upper normal limit 2) Total bilirubin\>2 fold of upper normal limit 3) CK\>2 fold of upper normal limit 4) Estimated Glomerular filtration rate\<60mL/min/1.73m2
• Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
• Smoke over 10 cigarettes per day or unable to stop smoking
• Subjects who previously participated in other clinical trials within 90 days
• Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
• Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
• Taking medications which induce or block medication metabolism
• History of drug abuse
• Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
• Disagree to contraception
• Subjects who are in any conditions impossible participating in the clinical trials

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

INHA University Hospital

Incheon, 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: December 13, 2018
• First Posted: January 4, 2019
• Study Start: September 5, 2018
• Primary Completion: October 23, 2018
• Study Completion: November 13, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)