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Phase 1 Safety and Relative Bioavailability Study of DWRX5003 in Healthy Adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWRX5003 | Experimental | DWRX5003 3 doses |
|
| DWC202502 | Active Comparator |
| |
| DWC202503 | Active Comparator |
| |
| DWRX5003P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWRX5003 | Drug | Microneedle patch containing Semaglutide |
| |
| DWC202502 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-t | Pre-dose (0 hour) up to 672 hours post-dose | |
| Cmax | Pre-dose (0 hour) up to 672 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0-8h, AUC 0-168h, AUCinf | Pre-dose (0 hour) up to 672 hours post-dose | |
| CL/F, Vd/F | Clearance, Volume of distribution | Pre-dose (0 hour) up to 672 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUEC0-5h, AUEC5-10h, iAUC0-5h, iAUC5-10h | Baseline (Day -1) to Day 8 | |
| Emax of glucose | Baseline (Day -1) to Day 8 | |
| AUEC0-168h, AUEC0-672h of glucose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JeongHwa Kim | Contact | +8225508317 | jeonghwa.kim@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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This study employs a partial double-blind design.
| Drug |
Semagluide |
|
| DWC202503 | Drug | Semaglutide |
|
| DWRX5003P | Other | placebo microneedle patch |
|
| Tmax, t½ | Tmax (time to reach maximum plasma concentration), t½ (elimination half-life) | Pre-dose (0 hour) up to 672 hours post-dose |
| Frel | Relative bioavailability compared to the active control | Pre-dose (0 hour) up to 672 hours post-dose |
| Baseline (Day -1) to Day 8 |
| body weight | baseline (day -1 ) to day 29 |
| BMI | baseline (day -1 ) to day 29 |
| waist circumference | baseline (day -1 ) to day 29 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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