Compare the Pharmacokinetics and Safety of CKD-391

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemias

Treatments: Drug: D090, D337; Drug: CKD-391 10/10mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04354987

152BE18037

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: CKD-391 10/10mg

Drug: D090, D337

Group B

Experimental group

Description:

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

Treatment:

Drug: CKD-391 10/10mg

Drug: D090, D337

Group C

Experimental group

Description:

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

Treatment:

Drug: CKD-391 10/10mg

Drug: D090, D337

Group D

Experimental group

Description:

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

Treatment:

Drug: CKD-391 10/10mg

Drug: D090, D337