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To evaluate the safety and pharmacokinetic characteristics after the administration of JT-001, JT-002 and JLP-2008
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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]) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | SGLT2 dual inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC over24H of JLP-2008 | 24 hours | |
| Cmax of JLP-2008 | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Those with a clinically significant history of hypersensitivity, intolerance, or anaphylaxis to the main ingredient or other components of the investigational product
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.)
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
Persons judged to be unsuitable as trial subjects in the test items conducted during screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang CHA university global clinical trials center Institutional Review Board | Gyeonggi-do | Bundang-gu | 13497 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42270920 | Derived | Roh WL, Shin W, Yoo H, Ahn KH, Lee Y, Kim A. JLP-2008 Fixed-Dose Combination Tablet Demonstrates Bioequivalence and Comparable Safety to Separate Dapagliflozin + Pioglitazone in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2026 Jun 10. doi: 10.1007/s13318-026-01014-0. Online ahead of print. |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| D045505 | Physiological Effects of Drugs |