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

Phase 1

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: T; Drug: R

• Registration Number: NCT03793985
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-05
• Primary Completion: 2018-10-23
• Study Completion: 2018-11-13
• Study First Submitted: 2018-12-13
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A (R+T+R+T)	T	Period 1 : R Period 2 : T Period 3 : R Period 4 : T
B (T+R+T+R)	T	Period 1 : T Period 2 : R Period 3 : T Period 4 : R
A (R+T+R+T)	R	Period 1 : R Period 2 : T Period 3 : R Period 4 : T
B (T+R+T+R)	R	Period 1 : T Period 2 : R Period 3 : T Period 4 : R

Primary Outcome Measures

Name	Time	Method
Cmax	0~72hours	To evaluate pharmacokinetic equivalence of experimental arm comparing Cmax
AUCt	0~72hours	To evaluate pharmacokinetic equivalence of experimental arm comparing AUCt

Trial Locations

Locations (1)

INHA University Hospital; 🇰🇷 Incheon, Korea, Republic of