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This is a randomized, open-label, three-sequence, three-period, three-treatment clinical trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir dipivoxil after oral administration in healthy male subjects.
To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil | Drug | Clevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Predose ~24hrs | |
| Cmax | Predose~24hrs |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | Predose~24hrs | |
| Tmax | Predose~24hrs | |
| T1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Seoul National University Hospital | Seoul | South Korea |
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| Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil | Drug | Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15; |
|
| Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil | Drug | Adefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15 |
|
| Predose~24hrs |
| CL/F | Predose~24hrs |
| Safety | clinically measured adverse events, abnormality of laboratory tests abnormality of vital signs,ECG e.t.c | Screening, predose, post 24h, Post-study visit |
| ID | Term |
|---|---|
| C034935 | clevudine |
| C106812 | adefovir dipivoxil |
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