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The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | Period 1: PK101-001, PK101-002 / Period 2: PK101 Number of subject: 23 Wash out Period: over 7 days (between each period) Dosage: Once daily, at 2D each period |
|
| Sequence B | Other | Period 1: PK101 / Period 2: PK101-001, P101-002 Number of subject: 23 Wash out Period: over 7 days (between each period) Dosage: Once daily, at 2D each period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PK101 | Combination Product | PK101-001 + PK101-002 (combination) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Area under the plasma/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002 | 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| Cmax | Maximum Plasma Concentration of PK101-002 | 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of peak concentration of PK101-002 | 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| AUCinf | Area under the plasma concentration versus time curve from zero to infinity of PK101-002 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jang-Hee Hong | Clinical Trials Center, Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Chungnam National University Hospital | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39560548 | Derived | Song JH, Koh H, Moon HY, Jung JG, Hong JH, Sunwoo J. Comparison of a fixed-dose combination of Celecoxib/PG201 [Layla(R)] versus co-administration of individual formulations in healthy participants: A randomized trial. Medicine (Baltimore). 2024 Nov 15;103(46):e40494. doi: 10.1097/MD.0000000000040494. |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| PK101-001, PK101-002 |
| Drug |
coadministration |
|
| 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| t1/2 | Terminal half life of PK101-002 | 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| CL/F | Clearance/Bioavailability of PK101-002 | 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |
| AUCt/AUCinf | AUCt/AUCinf of PK101-002 | 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |