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| ID | Type | Description | Link |
|---|---|---|---|
| Version 01 May 28, 2012 | Other Identifier | LAL ClĂnica |
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The objective of this clinical study, randomized, crossover is to evaluate the pharmacokinetic profile of the polypill (atorvastatin + lorsatana + hydrochlorothiazide) Laboratory Hypermarcas S / A, in relation to drugs Citalor ® (atovastatina - Pfizer) and Hyzaar ® (losartan + hydrochlorothiazide - Merck Sharp & Dohme) by comparing the serum concentration of analytes unchanged (AT, LS and HCTZ) in healthy subjects.
The pharmacokinetic profile of the drug will also be assessed by comparing the serum concentration of active metabolites following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | Citalor (Atorvastatin) - Pfizer |
|
| Hydrochlorothiazide + Losartan | Active Comparator | Hyzaar (Hydrochlorothiazide + Losartan) - Merck Sharp & Dohme |
|
| Atorvastatin + Hydrochlorothiazide + Losartan | Experimental | PolipĂlula (Atorvastatin + Hydrochlorothiazide + Losartan) - Lab Hypermarcas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary pharmacokinetic parameters for the exercise of comparability will be unchanged dosages of analytes (AT, LS and HCTZ), assessed by AUC, Tmax, Cmax and T1 / 2. | 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters are side dosages of active metabolites O-HAT and E-3174, measured by AUC, Tmax, Cmax and T1 / 2. | 0h00, 0h15, 0h30, 0h45, 1h00, 1h15, 1h30, 1h45, 2h00, 2h30, 3h00, 3h30, 4h00, 4h30, 5h00, 6h00, 8h00, 10h00, 12h00, 18h00, 24h00, 36h00, 48h00, 56h00 e 72h00. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL ClĂnica Pesquisa e Desenvolvimento Ltda | Valinhos | SĂŁo Paulo | Brazil |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| C505809 | hydrochlorothiazide, losartan drug combination |
| D006852 | Hydrochlorothiazide |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Hydrochlorothiazide + Losartan | Drug | 12.5 mg + 50 mg |
|
|
| Hydrochlorothiazide + Losartan + Atorvastatin | Drug | 12.5 mg + 50 mg + 10 mg |
|
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D013777 | Tetrazoles |