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This was an open-label, randomized, fasting, single-dose, 2-sequence, 2-period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
A total of 52 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fasting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (R1+R2+R3 / T) | Experimental | R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006 |
|
| Sequence B (T / R1+R2+R3) | Experimental | T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg | Drug | Orally administered once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variable - Cmax | Maximum plasma concentration of "BR3006" and "BR3006A," "BR3006B," and "BR3006C" | From Day 1, 0 hour (pre-dose) to Day 5 after dose administration |
| Pharmacokinetic variable - AUCt | Area under the drug concentration-time curve over the time interval of "BR3006" and "BR3006A," "BR3006B," and "BR3006C" | From Day 1, 0 hour (pre-dose) to Day 5 after dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shinyoung Oh | Contact | +82 2-708-8000 | syoh@boryung.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Recruiting | Seoul | Gwanak-gu | 08779 | South Korea |
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|
| Dapagliflozin 10 mg | Drug | Orally administered once per day |
|
|
| Pioglitazone 30 mg | Drug | Orally administered once per day |
|
|
| Metformin HCl 1000 mg | Drug | Orally administered once per day |
|
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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