Compare the Pharmacokinetics and Safety of CKD-391

Phase 1

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: CKD-391 10/10mg; Drug: D090, D337

• Registration Number: NCT04354987
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-30
• Primary Completion: 2020-01-09
• Study Completion: 2020-01-09
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-17
• Last Update Submitted: 2020-04-17
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group C	D090, D337	T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R
Group A	D090, D337	R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T
Group D	CKD-391 10/10mg	T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R
Group B	CKD-391 10/10mg	R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T
Group B	D090, D337	R+T+R+T Period 1 : R Period 2 : T Period 3 : R Period 4 : T
Group A	CKD-391 10/10mg	R+R+T+T Period 1 : R Period 2 : R Period 3 : T Period 4 : T
Group D	D090, D337	T+T+R+R Period 1 : T Period 2 : T Period 3 : R Period 4 : R
Group C	CKD-391 10/10mg	T+R+T+R Period 1 : T Period 2 : R Period 3 : T Period 4 : R

Primary Outcome Measures

Name	Time	Method
AUCt	0~72hours	To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt; 1) Atorvastatin, unconjugated ezetimibe(AUCt)
Cmax	0~72hours	To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax; 1) Atorvastatin, unconjugated ezetimibe(Cmax)

Trial Locations

Locations (1)

Jae-Yong Chung; 🇰🇷 Gyeonggi-do, Seongnam-si, Korea, Republic of