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This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-L01 25/1,000 mg FDC Tablet | Experimental | Alogliptin Benzoate 25 mg/Metformin HCl XR 1,000 mg, FDC Tablet |
|
| Alogliptin Benzoate 25 mg, Metformin HCl XR 1,000 mg | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-L01 | Drug | FDC tablet, single dose, oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast (Area under the plasma concentration-time curve) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours | |
| Cmax (Peak Plasma Concentration) | Pre-dose(0.00), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf (Area under the plasma concentration-time curve from time 0 to infinity) | Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours | |
| AUClast/AUCinf | Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
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| Alogliptin Benzoate 25 mg |
| Drug |
Alogliptin Benzoate 25 mg, oral administration |
|
| Metformin HCl XR 1,000 mg | Drug | Metformin HCl XR 1,000 mg, oral administration |
|
| Tmax (Time of peak plasma concentration) | Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |
| t1/2 (Half-life) | Pre-dose(0), 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, and 72.00 hours |