Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: CKD-519 100mg 1Cap.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 50mg 2Tabs.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02623868

148NF15010

Details and patient eligibility

About

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

Full description

Open-label, Randomized, 3-period, 6-sequence, crossover study

Enrollment: 30 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Between 20 aged and 45 aged in healthy male adult
2. Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
3. Subject who sign on an informed consent form willingly
4. Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products

Exclusion criteria

1. Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
2. Have a acute disease within 28 days before the beginning of study treatment
3. Have a disease history that can effect drug absorption, distribution, metabolism, excretion
4. Have a clinically significant chronic disease
5. Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg
6. Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
7. Subject treated ethical drug within 14 days before the beginning of study treatment
8. Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
9. Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
10. Cannot take standard Meal
11. Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
12. Blood transfusion within 30 days
13. Taking drugs have received any other investigational drug within 90 days prior to the first dosing
14. Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day)
15. Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
16. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Group 1

Experimental group

Description:

A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Treatment:

Drug: CKD-519 50mg 2Tabs.

Drug: CKD-519 100mg 1Cap.

Drug: CKD-519 100mg 1Tab.

Group 2

Experimental group

Description:

B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Treatment:

Drug: CKD-519 50mg 2Tabs.

Drug: CKD-519 100mg 1Cap.

Drug: CKD-519 100mg 1Tab.

Group 3

Experimental group

Description:

C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Treatment:

Drug: CKD-519 50mg 2Tabs.

Drug: CKD-519 100mg 1Cap.

Drug: CKD-519 100mg 1Tab.

Group 4

Experimental group

Description:

A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Treatment:

Drug: CKD-519 50mg 2Tabs.

Drug: CKD-519 100mg 1Cap.

Drug: CKD-519 100mg 1Tab.

Group 5

Experimental group

Description:

B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Treatment:

Drug: CKD-519 50mg 2Tabs.

Drug: CKD-519 100mg 1Cap.

Drug: CKD-519 100mg 1Tab.

Group 6

Experimental group

Description:

C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)

Treatment:

Drug: CKD-519 50mg 2Tabs.

Drug: CKD-519 100mg 1Cap.

Drug: CKD-519 100mg 1Tab.