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To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901
An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment(Experimental): JLP-1901 | Experimental | Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008]) |
|
| Control(Active Comparator): JC-001 | Active Comparator | Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008]) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JLP-1901 | Drug | administration of JLP-1901 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC over 24H of JLP-1901 | AUC over 24H | 24 hours |
| Cmax of JLP-1901 | Cmax | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
A subject who shows the following values as a result of a laboratory test:
☞ ALT or AST > 2 times the upper limit of normal range
Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)
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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 |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| JC-001(active comparator) | Drug | administration of JC-001(tenofovir) |
|
|
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |