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The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB80380 maleat salt | Experimental |
| |
| LB80380 free base | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB80380 maleate salt | Drug | 183 mg (150 mg as a free base) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | up to 144 hours | |
| Cmax | up to 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability | up to 7 days | |
| Profile of Pharmacokinetics | Tmax, Aet, CL/F | up to 144 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wooseong Huh, Prof | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center, Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22981147 | Derived | Jung JA, Kim SR, Kim TE, Kim JR, Lee SY, Huh W, Ko JW. Pharmacokinetic comparison of the maleate and free base formulations of LB80380, a novel nucleotide analog, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012 Sep;50(9):657-64. doi: 10.5414/cp201716. |
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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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| LB80380 free base |
| Drug |
150 mg |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |