---
title: To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008
nct_id: NCT06165965
overall_status: COMPLETED
phase: PHASE1
sponsor: Jeil Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Healthy Adult
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06165965.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06165965"
ct_last_update_post_date: 2023-12-12
last_seen_at: "2026-05-12T07:18:15.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008

**Official Title:** A Randomized, Open-label, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of JLP-2008 and the Co-admin. of JT-001, and JT-002 for Healthy Subjects in Fasted State

**NCT ID:** [NCT06165965](https://clinicaltrials.gov/study/NCT06165965)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 48
- **Lead Sponsor:** Jeil Pharmaceutical Co., Ltd.
- **Conditions:** Healthy Adult
- **Start Date:** 2022-05-03
- **Completion Date:** 2022-06-27
- **CT.gov Last Update:** 2023-12-12

## Brief Summary

To evaluate the safety and pharmacokinetic characteristics after the administration of JT-001, JT-002 and JLP-2008

## Detailed Description

A randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of JLP-2008 and the co-administration of JT-001, and JT-002 for healthy subjects in fasted state

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Healthy adults between 19 and 55 years of age at the time of screening test
2. At the time of the screening test, a subject weighing more than 50 kg for men and 45 kg for women, and a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less.
3. After receiving a detailed explanation of this clinical trial and fully understanding it, those who voluntarily decide to participate and give written consent before the screening procedure

Exclusion Criteria:

1. Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
2. Those who have clinically siginificant medical history of liver (severe liver disorders, etc.), kidneys (severe renal disorders, etc.), digestive system (pancreatitis, etc.), respiratory system, musculoskeletal system, endocrine system (diabetic ketoacidosis, diabetic coma and precoma, type 1 Diabetes mellitus), neuropsychiatric, hematologic/oncological, and cardiovascular (heart failure, orthostatic hypotension, etc.)
3. Those with a history of Gastrointestinal disease (e.g. Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia surgery, endoscopic polyp surgery, hemorrhoids, dentition, and fistula surgery) that may affect the absorption of the investigational product
4. Persons judged to be unsuitable as trial subjects in the test items conducted during screening

   * Blood ALT, AST, Total bilirubin \> 2 times the upper limit of normal range
   * eGFR \< 60 mL/min/1.73m2 (using CKD-EPI formula)
   * HBsAg, HCV Ab, HIV, Syphilis regain test (RPR) results are positive
   * Vital signs measured in the sitting position after resting for more than 3 minutes: systolic blood pressure \> 160 mmHg or \< 90 mmHg, or diastolic blood pressure \> 100 mmHg or \< 50 mmHg
```

## Arms

- **Treatment(Experimental): JLP-2008** (EXPERIMENTAL) — \- Group I(Peroid I-Comparator\[JT-001,JT-002\], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator\[JT-001,JT-002\])
- **Control(Active Comparator): JC-013** (ACTIVE_COMPARATOR) — \- Group I(Peroid I-Comparator\[JT-001,JT-002\], Peroid II-JLP-2008), Group II(Period I-JLP-2008, Period II-Comparator\[JT-001,JT-002\])

## Interventions

- **SGLT2 inhibitor** (DRUG) — SGLT2 dual inhibitor

## Primary Outcomes

- **AUC over24H of JLP-2008** _(time frame: 24 hours)_
- **Cmax of JLP-2008** _(time frame: 24 hours)_

## Locations (1)

- Bundang CHA university global clinical trials center Institutional Review Board, Gyeonggi-do, Bundang-gu, South Korea

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.bundang cha university global clinical trials center institutional review board|gyeonggi-do|bundang-gu|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06165965.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06165965*  
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