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To compare and evaluate safety and pharmacokinetic Characteristics after administration of ATB-101 or co-administration of ATB-1011 and ATB-1012 in fasted Healthy Adult Volunteers
Pharmacokinetic endpoints
Safety evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A=Reference-Test | Active Comparator | T(Test drug): ATB-101 R1(Reference drug1): ATB-1011 R2(Reference drug2): ATB-1012 First stage: co-administration of R1 and R2, single dose and then Washout: 7days and then Second stage: administration of T, single dose |
|
| Sequence B=Test-Reference | Active Comparator | First stage: administration of T, single dose and then Washout: 7days and then Second stage: co-administration of R1 and R2, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATB-101, ATB-1011, ATB-1012 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Olmesartan | Area under the concentration-time curve | Day1(first stage), Day8(scond stage) |
| Cmax of Olmesartan | Maximum concentration of drug in plasma | Day1(first stage), Day8(scond stage) |
| AUCt of Dapagliflozin | Area under the concentration-time curve | Day1(first stage), Day8(scond stage) |
| Cmax of Dapagliflozin | Maximum concentration of drug in plasma | Day1(first stage), Day8(scond stage) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC∞ of Olmesartan | Area under the plasma drug concentration-time curve from time 0 to infinity | Day1(first stage), Day8(scond stage) |
| Tmax of Olmesartan | Time to maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaewoo Kim | H + Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | Gwanak-gu | 08779 | South Korea |
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Open, Randomization, single oral administration, 2 Intervention group, crossover design
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| Day1(first stage), Day8(scond stage) |
| T1/2 of Olmesartan | Terminal elimination half-life | Day1(first stage), Day8(scond stage) |
| CL/F of Olmesartan | Apparent total clearance of the drug from plasma after oral administration | Day1(first stage), Day8(scond stage) |
| Vd/F of Olmesartan | Apparent volume of distribution after non-intravenous administration | Day1(first stage), Day8(scond stage) |
| AUC∞ of Dapagliflozin | Area under the plasma drug concentration-time curve from time 0 to infinity | Day1(first stage), Day8(scond stage) |
| Tmax of Dapagliflozin | Time to maximum plasma concentration | Day1(first stage), Day8(scond stage) |
| T1/2 of Dapagliflozin | Terminal elimination half-life | Day1(first stage), Day8(scond stage) |
| CL/F of Dapagliflozin | Apparent total clearance of the drug from plasma after oral administration | Day1(first stage), Day8(scond stage) |
| Vd/F of Dapagliflozin | Apparent volume of distribution after non-intravenous administration | Day1(first stage), Day8(scond stage) |