Compare the Pharmacokinetics and Safety of CKD-391

Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-391 With Co-administration of D090 and D337 in Healthy Adult Volunteers

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

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: CKD-391 10/10mg; Drug: D090, D337

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam-si
    • Gyeonggi-do, Seongnam-si, Korea, Republic of, 463-707
      • Jae-Yong Chung

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. 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.
3. Not abnormal or not clinically significant lab values.
4. 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. unable to stop drinking and smoking during clinical trials
6. Subjects who donated whole blood within 60 days or donated component blood within 30 days or received blood transfusion within 30 days
7. History of drug abuse
8. Disagree to contraception
9. 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T	Drug: CKD-391 10/10mg; Drug T: CKD-391 10/10mg(Other Name: Test Drug); Other Names: Test Drug (T); Drug: D090, D337; D090 and D337 co-administration(Other Name: Reference drug); Other Names: Reference Drug (R)
Experimental: Group B; R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T	Drug: CKD-391 10/10mg; Drug T: CKD-391 10/10mg(Other Name: Test Drug); Other Names: Test Drug (T); Drug: D090, D337; D090 and D337 co-administration(Other Name: Reference drug); Other Names: Reference Drug (R)
Experimental: Group C; T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R	Drug: CKD-391 10/10mg; Drug T: CKD-391 10/10mg(Other Name: Test Drug); Other Names: Test Drug (T); Drug: D090, D337; D090 and D337 co-administration(Other Name: Reference drug); Other Names: Reference Drug (R)
Experimental: Group D; T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R	Drug: CKD-391 10/10mg; Drug T: CKD-391 10/10mg(Other Name: Test Drug); Other Names: Test Drug (T); Drug: D090, D337; D090 and D337 co-administration(Other Name: Reference drug); Other Names: Reference Drug (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): January 9, 2020
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: 152BE18037

Drug and device information, study documents

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