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The goal of this Phase 1 clinical trial is to compare the pharmacokinetics and safety of a fixed-dose combination tablet (ATB-U101) versus co-administration of its individual components in healthy Caucasian adult volunteers. The main questions it aims to answer are:
Researchers will compare ATB-U101 (fixed-dose combination, 40 mg/10 mg) against two reference co-administrations - ATB-1011+ATB-1012 (Korean-approved Olmetec + Forxiga) and ATB-U1011+ATB-U1012 (US-approved Benicar + Farxiga) - to see if the 90% confidence intervals of the geometric mean ratios for the primary PK parameters fall within the bioequivalence range of 80.00-125.00%.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATB-U101 | Experimental |
| |
| ATB-1011 and ATB-1012 | Experimental |
| |
| ATB-U1011 and ATB-U1012 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATB-U101 | Drug | ATB-U101 is a fixed-dose combination tablet containing Olmesartan medoxomil 40 mg and Dapagliflozin 10 mg. A single oral dose will be administered under fasting conditions (minimum 10 hours) with 240 mL of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Olmesartan | Pre-dose (0h) through 48 hours post-dose | |
| AUClast of Olmesartan | Pre-dose (0h) through 48 hours post-dose | |
| Cmax of Dapagliflozin | Pre-dose (0h) through 48 hours post-dose | |
| AUClast of Dapagliflzin | Pre-dose (0h) through 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eunji Byeon | Contact | 82-70-4484-5587 | ejb@autotelic.co.kr |
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| ATB-1011 | Drug | ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water. |
|
| ATB-U1011 | Drug | ATB-U1011 (Benicar, Olmesartan medoxomil 40 mg) and ATB-U1012 (Farxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water. |
|
| ATB-1012 | Drug | ATB-1011 (Olmetec, Olmesartan medoxomil 40 mg) and ATB-1012 (Forxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water. |
|
| ATB-U1012 | Drug | ATB-U1011 (Benicar, Olmesartan medoxomil 40 mg) and ATB-U1012 (Farxiga, Dapagliflozin 10 mg) will be co-administered as a single oral dose under fasting conditions (minimum 10 hours) with 240 mL of water. |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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