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To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence (1) | Experimental | Number of Subject: 24 Wash out Period: over 7 days (between each period) Investigators Products(IPs) for Period1: A (Single)= PK101-002 IPs for Period2: B (Combination)= PK101-001, PK101-002 |
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| Sequence (2) | Experimental | Number of Subject: 24 Wash out Period: over 7 days (between each period) IPs for Period1: B (Combination)= PK101-001, PK101-002 IPs for Period2: A (Single)= PK101-002 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PK101-002 | Drug | -(Single) PK101-002 |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ | Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times) | 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| Cmax,ss | The maximum (or peak) serum concentration for PK101-002 at Steady-state | 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Hyun Kang | H Plus Yangji Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Clinical Research Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| PK101 | Combination Product | -(Combination) PK101-001, PK101-002 |
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