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This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDC YH16410 | Experimental | Drug: Test treatment: FDC YH16410 (Telmisartan 80mg/ Rosuvastatin 20mg). Subjects will receive single oral dose of 1 tablet of FDC containing Telmisartan 80mg and Rosuvastatin 20mg in fasted state |
|
| Co-administration | Active Comparator | Drug: Reference Treatment: Co-administration(Telmisartan 80mg and Rosuvastatin 20mg). Subjects will receive 1 x Telmisartan 80mg with 1 x Rosuvastatin 20mg tablet administered orally in fasted state as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC | Drug | For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments | 0~72hr, 17points |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| D002318 | Cardiovascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |