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To compare the pharmacokinetic characteristics between HCP1201 tablet 750/10 mg and co-administration of metformin 750 mg plus rosuvastatin 10 mg under fed state condition.
An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After the Administration of HCP1201 Tablet 750/10 mg and Coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg in Healthy Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCP1201 | Experimental | Participants received a single oral dose of the HCP1201 750/10 mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2). |
|
| Metformin and Rosuvastatin | Active Comparator | Participants received a single oral dose of coadministration of Metformin SR 750 mg and Rosuvastatin 10 mg under fed condition, on Period 1(for participants randomized to Sequence 1) or on Period 2(for participants randomized to Sequence 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1201 750/10mg | Drug | 750mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| metformin, rosuvastatin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | |
| metformin, rosuvastatin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h |
| Measure | Description | Time Frame |
|---|---|---|
| Metformin, rosuvastatin Tmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h | |
| Metformin, rosuvastatin T1/2 | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jung-Ryul Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| 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 |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Metformin SR 750mg | Drug | Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8. |
|
|
| Rosuvastatin 10mg | Drug | Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8. |
|
|
| Metformin, rosuvastatin AUCinf | pre-dose, post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 48 h |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |