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This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viread → DA-2802 | Experimental |
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| DA-2802 → Viread | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viread 300mg | Drug | single dose administration after 10hr fasting |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve(AUC)last of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | |
| Maximum of concentration(Cmax) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration(Tmax) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose | |
| Terminal half-life(t1/2) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, Ph.D, M.B.A | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| DA-2802 319mg | Drug | single dose administration after 10hr fasting |
|
|
| Apparent Clearance(CL/F) of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| Area Under Curve(AUC)inf of Tenofovir | 0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |