## Protocol Section
### Identification Module
**NCT ID:** NCT06431399

**Brief Title:** To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004

**Official Title:** A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 in Healthy Adult Volunteers

#### Organization Study ID Info
**ID:** JP-2004-102
#### Organization
**Class:** INDUSTRY
**Full Name:** Jeil Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2024-07-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Jeil Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004

**Detailed Description:** A randomized, open-label, crossover phase 1 clinical trial to evaluate the safety, pharmacokinetic characteristics and the effect of food after administration of JLP-2004 in healthy adult volunteers

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Thin arm is JLP-2004 FAST condition

**Intervention Names:**

- Drug: JLP-2004 qd

**Label:** JLP-2004 FAST

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Thin arm is JLP-2004 FED condition

**Intervention Names:**

- Drug: JLP-2004 qd

**Label:** JLP-2004 FED

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- JLP-2004 FAST

- JLP-2004 FED

**Description:** Group I(Peroid I-JLP-2004 FAST, Peroid II-JLP-2004 FED), Group II(Period I-JLP-2004 FED, Period II-JLP-2004 FAST)

**Name:** JLP-2004 qd

**Other Names:**

- painkiller

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** AUCt of JLP-2004 in FAST and FED condition

**Measure:** AUCt of JLP-2004

**Time Frame:** after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour

**Description:** Cmax of JLP-2004 in FAST and FED condition

**Measure:** Cmax of JLP-2004

**Time Frame:** after treatment 0hour, 0.5hour, 1hour, 2hour, 3hour, 24hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Healthy adult volunteers aged 19 years or older at the time of screening
2. At the time of screening, those who weigh more than 50.0 kg and have a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of internal medical examination (if necessary, electroencephalography, electrocardiogram, chest and stomach endoscopy, or gastrointestinal radiography)
4. Those who be considered suitable for clinical subjects according to the results of laboratory tests (hematology tests, blood chemistry tests, urine tests, serum tests, blood coagulation tests, urine drugs tests), physical examinations and 12-lead electrocardiography at the time of screening
5. Those who voluntarily decide to participate and agree in writing to comply with the subject compliance requirements during the clinical trial period after receiving a detailed explanation of this clinical trial and fully understanding it

Exclusion Criteria:

1. Those who have current or past medical history of clinically significant liver, kidney, nervous system, mental, respiratory, endocrine, blood disease, tumor, genitourinary, cardiovascular, digestive, and musculoskeletal systems, as well as the following symptoms or history.

   ① Renal impairment

   ② Liver disorder
2. For women, pregnant women (Urine-HCG positive) or breastfeeding mother
3. Those who have clinically significant hypersensitivity reactions such as asthma, hives, allergies, etc. to the main ingredient (Pelubiprofen), additives, or other drugs (aspirin or other non-steroidal anti-inflammatory drugs (including COX-2 inhibitors)) and have a history of hypersensitivity reaction
4. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
5. Those with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs

**Healthy Volunteers:** True

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cbnuhkimdajin@cbnuh.or.kr

**Name:** DAJIN KIM

**Phone:** 043-269-6781

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chungju

**Contacts:**

***Contact 1:***

- **Email:** cbnuhkimdajin@cbnuh.or.kr

- **Name:** DAJIN KIM

- **Phone:** 043-269-6781

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Chungbuk National University Hospital

**State:** Seowon-gu

**Status:** RECRUITING

**Zip:** 28644

#### Overall Officials

**Official 1:**

**Affiliation:** Chungbuk National University Hospital

**Name:** Minkyu Park

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4032

- Name: Analgesics

- Relevance: HIGH

- As Found: Laparoscopic Splenectomy

### Intervention Browse Module - Meshes

- ID: D000000700

- Term: Analgesics

### Misc Info Module

- Version Holder: 2024-05-31
