## Protocol Section
### Identification Module
**NCT ID:** NCT03920579

**Brief Title:** A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Male Volunteers

**Official Title:** A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers

#### Organization Study ID Info
**ID:** 183PK18034
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2019-05

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-04-19

**Type:** ACTUAL

**Last Update Submit Date:** 2019-04-17

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-04-01

**Type:** ACTUAL

**Status Verified Date:** 2019-04

#### Study First Post Date
**Date:** 2019-04-19
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-08
**Study First Submit QC Date:** 2019-04-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chong Kun Dang Pharmaceutical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

**Detailed Description:** A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers

### Conditions Module

**Conditions:**

- Hypertension

- Dyslipidemias

**Keywords:**

- CKD-386

- Pharmacokinetics

- D326

- D337

- D013

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)

**Intervention Names:**

- Drug: CKD-386 formulation 1

- Drug: CKD-386 formulation 2

- Drug: D326, D337 and D013

**Label:** Sequence 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)

**Intervention Names:**

- Drug: CKD-386 formulation 1

- Drug: CKD-386 formulation 2

- Drug: D326, D337 and D013

**Label:** Sequence 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)

**Intervention Names:**

- Drug: CKD-386 formulation 1

- Drug: CKD-386 formulation 2

- Drug: D326, D337 and D013

**Label:** Sequence 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013

**Intervention Names:**

- Drug: CKD-386 formulation 1

- Drug: CKD-386 formulation 2

- Drug: D326, D337 and D013

**Label:** Sequence 4

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)

**Intervention Names:**

- Drug: CKD-386 formulation 1

- Drug: CKD-386 formulation 2

- Drug: D326, D337 and D013

**Label:** Sequence 5

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)

**Intervention Names:**

- Drug: CKD-386 formulation 1

- Drug: CKD-386 formulation 2

- Drug: D326, D337 and D013

**Label:** Sequence 6

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sequence 1

- Sequence 2

- Sequence 3

- Sequence 4

- Sequence 5

- Sequence 6

**Description:** A single oral dose of 1 tablet under fasting conditions for each period

**Name:** CKD-386 formulation 1

**Other Names:**

- CKD-386 Test 1

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Sequence 1

- Sequence 2

- Sequence 3

- Sequence 4

- Sequence 5

- Sequence 6

**Description:** A single oral dose of 1 tablet under fasting conditions for each period

**Name:** CKD-386 formulation 2

**Other Names:**

- CKD-386 Test 2

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Sequence 1

- Sequence 2

- Sequence 3

- Sequence 4

- Sequence 5

- Sequence 6

**Description:** A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period

**Name:** D326, D337 and D013

**Other Names:**

- CKD-386 Reference

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** AUC0-t: Area under the concentration-time curve from time zero to time

**Measure:** AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

**Description:** Cmax: Maximum plasma concentration of the drug

**Measure:** Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

#### Secondary Outcomes

**Description:** AUCinf: Area under the concentration-time curve from zero up to ∞

**Measure:** AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31

**Description:** Tmax: Time to maximum plasma concentration

**Measure:** Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

**Description:** t1/2: Terminal elimination half-life

**Measure:** t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

**Description:** CL/F: Apparent total body clearance of the drug

**Measure:** CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

**Description:** Vd/F: Apparent volume of distribution

**Measure:** Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

**Description:** AUC0-t: Area under the concentration-time curve from time zero to time

**Measure:** AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

**Description:** Cmax: Maximum plasma concentration of the drug

**Measure:** Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013

**Time Frame:** 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Healthy volunteers aged between ≥20 and ≤45 years old
2. Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
4. Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
2. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
3. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 19 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** dsshin@gilhospital.com

**Name:** Dongseong Shin, M.D, Ph.D

**Phone:** +82-32-460-9459

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Incheon

**Contacts:**

***Contact 1:***

- **Email:** dsshin@gilhospital.com

- **Name:** Dongseong Shin, M.D, Ph.D

- **Phone:** +82-32-460-9459

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Gachon University Gil Medical Center

**Status:** RECRUITING

**Zip:** 21565

#### Overall Officials

**Official 1:**

**Affiliation:** Clinical Trials Center, Gil Medical Center, Incheon, Korea

**Name:** Dongseong Shin, M.D, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000052439

- Term: Lipid Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M26181

- Name: Dyslipidemias

- Relevance: HIGH

- As Found: Dyslipidemia

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27029

- Name: Lipid Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050171

- Term: Dyslipidemias

### Misc Info Module

- Version Holder: 2024-05-24
