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This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202108, DWC202109) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | P1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg |
|
| Treatment B | Active Comparator | P1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg |
|
| Treatment C | Active Comparator | P1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg |
|
| Treatment D | Active Comparator | P1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic Acid 250 Mg Oral Tablet | Drug | Administration of Ursodeoxycholic Acid 250 Mg Oral Tablet or Ursodeoxycholic Acid 100 Mg Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t | Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t | -48 - 72hours |
| Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax | Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax | -48 - 72hours |
| Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t | Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t | -48 - 72hours |
| Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax | Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax | -48 - 72hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BoHyung Kim<bhkim98@gmail.com> Kim, MD, PhD | Kyung Hee University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Medical Hospital | Seoul | Korea, Republic of | 02447 | South Korea |
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4 by 3 cross-over study
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|
| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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