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This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 or 2 or 3 | Experimental | [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8010 5mg | Drug | [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration of DA-8010 (Cmax) | 0~48hours | |
| Area under the plasma concentration versus time curve of DA-8010 (AUClast) | 0~48hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000630740 | DA-8010 |
| D017291 | Clarithromycin |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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3-period
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| Clarithromycin 500mg | Drug | [Period 2] DA-8010 5mg, Clarithromycin 500mg |
|
| Rifampicin 600mg | Drug | [Period 3] DA-8010 5mg, Rifampicin 600mg |
|
| Organic Chemicals |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |