Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers.
The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting and fed states in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Sequence I | Experimental | Period I: Forxiga® → DA-2811, Period II: DA-2811 → Forxiga® |
|
| Part A, Sequence II | Experimental | Period I: DA-2811 → Forxiga®, Period II: Forxiga® → DA-2811 |
|
| Part B, Sequence I | Experimental | Period I: DA-2811 under fasting state → DA-2811 under fed state, Period II:DA-2811 under fed state → DA-2811 under fasting state |
|
| Part B, Sequence II | Experimental | Period I: DA-2811 under fed state → DA-2811 under fasting state, Period II: DA-2811 under fasting state → DA-2811 under fed state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forxiga | Drug | single dose administration after 10hr fasting |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Area under the plasma concentration-time curve from time zero to time the last quantifiable time | pre-dose~48 hours post-dose |
| Cmax | Maximum plasma concentration | pre-dose~48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0 - ∞) | Area under the plasma concentration versus time curve from time zero to extrapolated infinite time (0 - ∞) | pre-dose~48 hours post-dose |
| Tmax | Time to reach maximum plasma concentration following drug administration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JaeYong Chung | Bundang Seoul National University Hospital Clinical Trial Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundangseoul national unversity hospital | Sŏngnam | GyeonggiDo | South Korea |
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DA-2811 | Drug | single dose administration after 10hr fasting |
|
| DA-2811 | Drug | single dose administration after 10hr fasting |
|
| DA-2811 | Drug | single dose administration after high fat and calorie fed diet |
|
| pre-dose~48 hours post-dose |
| t1/2 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | pre-dose~48 hours post dose |