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The purpose of this study is to compare the safety and pharmacokinetics of CKD-390(Tenofovir Disoproxil Aspartate) and Viread® tablet(Tenofovir Disoproxil Fumarate) in healthy male volunteers.
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viread® tablet | Active Comparator | Tenofovir Disoproxil Fumarate |
|
| CKD-390 | Experimental | Tenofovir Disoproxil Fumarate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-390 | Drug | Tenofovir Disoproxil Aspartate 1T PO |
| |
| Viread® tablet |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Tenofovir | 0(Pre-dose) up to 72hr |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | 0(Pre-dose) up to 72hr | |
| Blood pressure | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day | |
| tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang Hee Hong, MD, PhD | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Jung-gu | 301-721 | South Korea |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | 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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| Drug |
Tenofovir Disoproxil Fumarate 1T PO |
|
| 0(Pre-dose) up to 72hr |
| t1/2β | 0(Pre-dose) up to 72hr |
| Clearance/F | 0(Pre-dose) up to 72hr |
| Electrocardiography | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| Physical Examination | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| Pulse rate | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| Temperature | 1 day, 2 day, 3 day, 4 day, 15 day 16 day, 17 day 18 day, 25 day |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |