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

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D086 and D337 in Healthy Adult Volunteers

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

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: T; Drug: R

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Between 19 aged and 45 aged in healthy male adult
2. Over 50 kg, BMI between 18.0-29.0 kg/m2
3. 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.
4. Not abnormal or not clinically significant lab values.
5. Subjects who signed informed consent form with good understandings after explanations by investigators.

Exclusion Criteria:

1. No history or presence of clinically significant diseases.
2. Subjects showing adverse reaction to investigational product
3. Genetic problems in galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
4. History of myopathy
5. 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
6. Drink over 21 units/week (1 unit= 10g=12.5mL of pure alcohol) or unable to stop drinking during clinical trials
7. Smoke over 10 cigarettes per day or unable to stop smoking
8. Subjects who previously participated in other clinical trials within 90 days
9. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
10. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 10 days.
11. Taking medications which induce or block medication metabolism
12. History of drug abuse
13. Subjects who took any prescribed medications or oriental medicines within 14 days, or took any pharmacy medicines within 7 days.
14. Disagree to contraception
15. Subjects who are in any conditions impossible participating in the clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A (R+T+R+T); Period 1 : R Period 2 : T Period 3 : R Period 4 : T	Drug: T; CKD-391 40/10mg; Other Names: Test Drug; Drug: R; D086 and D337 co-administration; Other Names: Reference drug
Active Comparator: B (T+R+T+R); Period 1 : T Period 2 : R Period 3 : T Period 4 : R	Drug: T; CKD-391 40/10mg; Other Names: Test Drug; Drug: R; D086 and D337 co-administration; Other Names: Reference drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax	0~72hours
AUCt	To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt	0~72hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): October 23, 2018
• Study Completion (Actual): November 13, 2018

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 4, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: 152BE17006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No