Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects

NCT ID: NCT03175835

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2017-06-19

Brief Summary

The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.

Detailed Description

An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.

Conditions

Dyslipidemias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin 20 mg & CKD-519 200 mg

Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet))

Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets))

Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets))

Group Type: EXPERIMENTAL

Rosuvastatin 20 mg

Intervention Type: DRUG

Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1\~Day5

CKD-519 200 mg

Intervention Type: DRUG

Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9\~Day21

Rosuvastatin 20 mg & CKD-519 200 mg

Intervention Type: DRUG

Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22\~Day26

Interventions

Rosuvastatin 20 mg

Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1\~Day5

Intervention Type: DRUG

CKD-519 200 mg

Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9\~Day21

Intervention Type: DRUG

Rosuvastatin 20 mg & CKD-519 200 mg

Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22\~Day26

Intervention Type: DRUG

Other Intervention Names

Rosuvastatin 20 mg(20 mg X 1 tablet); CKD-519 200 mg(100 mg X 2 tablets); Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old

2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²

3. Subjects to consents to use effective birth controls for at least 2 months following the last dose

4. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written

Exclusion Criteria

1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder

2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration

3. Any medical history that may affect drug absorption, distribution, metabolism and excretion

4. Any hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of statin-related medication or Cholesteryl Ester Transfer Protein(CETP) inhibitor or other drugs(aspirin, antibiotics)

5. Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase > 3 fold upper normal limit(UNL)

6. Severe renal failure(creatinin clearance < 30 ml/min)

7. Hypothyroidism or clinically significant test result

8. Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders

9. Any clinically significant chronic medical illness

10. Any clinically significant hypotension or hypertension (systolic < 100 mmHg/diastolic < 60 mmHg or systolic > 140 mmHg /diastolic > 90 mmHg)

11. Corrected QT interval(QTc) >450msec on 12-lead ECG

12. Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL)

13. Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL)

14. Use of any prescription drugs within 14 days prior to study drug administration

15. Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration

16. History of clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not require any treatment may be allowed)

17. Inability to take normal hospital diet

18. Donation of blood within 60 days prior to study drug administration or plasma to a blood bank within 20 days prior to study drug administration

19. Blood transfusion within 30 days prior to study drug administration

20. Exposure to any investigational drug or placebo within 90 days prior to the first Investigational Product(IP) administration

21. Subjects taking any drugs to induce or inhibit drug metabolizing enzymes including barbiturates within 30 days prior to the first Investigational Product(IP) administration

22. Subjects with excessive caffeine intake (more than 5 cups/day), heavy smoking (more than 10 cigarettes/day), regular alcohol intake (more than 210 g/week)

23. Subjects having been deemed inappropriate for the trial as determined by the investigator

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

148DDI16023

Identifier Type: -

Identifier Source: org_study_id