Compare the Pharmacokinetics and Safety of CKD-391

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354987
• Other study ID #: 152BE18037
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2019
• Est. completion date: January 9, 2020

Study information

• Verified date: April 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• CKD-391 10/10mg
Drug T: CKD-391 10/10mg(Other Name: Test Drug)
• D090, D337
D090 and D337 co-administration(Other Name: Reference drug)

Locations

Country	Name	City	State
Korea, Republic of	Jae-Yong Chung	Gyeonggi-do	Seongnam-si

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax; 1) Atorvastatin, unconjugated ezetimibe(Cmax)	0~72hours
Primary	AUCt	To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt; 1) Atorvastatin, unconjugated ezetimibe(AUCt)	0~72hours