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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Compared to those of Caucasians, the plasma levels of atazanavir (ATV) may be higher in Koreans with the same dosage regimen(s). If so, even unboosted ATV could be used with tenofovir DF (TDF) which lowers the concentration of ATV. The investigators plan to investigate the pharmacokinetic features of ATV with or without TDF in healthy Korean and Caucasian volunteers and compare the ethnic differences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atazanavir | Experimental | 400 mg/day for 2 days |
|
| Atazanavir and Tenofovir | Experimental |
| |
| Atazanavir and Ritonavir | Experimental |
| |
| Atazanavir + tenofovir + ritonavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atazanavir | Drug | 400 mg/day for 2 days |
| |
| Atazanavir(ATZ) and Tenofovir(TDF) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis | maximum concentration at steady status(Cmax,ss) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic evaluation | Area under the time-concentration curve, at steady status, at tau(Ï„) (AUCÏ„,ss) |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyun-Seop Bae, M.D., Ph. D. | Contact | 82-2-3010-4622 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Songpa-gu | Seoul | 138-736 | South Korea |
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| Drug |
ATZ 400 mg with TDF/day for 2 days |
|
| Atazanavir(ATZ) + Ritonavir | Drug | ATZ 300 mg + Ritonavir 100 mg/day for 2 days |
|
| atazanavir(ATZ) + tenofovir(TDF) + ritonavir | Drug | ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days |
|
| ID | Term |
|---|---|
| D000069446 | Atazanavir Sulfate |
| D000068698 | Tenofovir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
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