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| ID | Type | Description | Link |
|---|---|---|---|
| IMPACT 15381 |
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| Name | Class |
|---|---|
| Scentryphar Clinical Research | OTHER |
| Cori Analyticals | UNKNOWN |
| Hospital Sirio-Libanes | OTHER |
| LabClin Laboratório Clínico |
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The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Other | 3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan (test) | Drug | 16 mg oral tablet, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. | 76 blood samples per subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Abib Junior, MD | Scentryphar Clinical Research | Principal Investigator |
| Moises L. P Vanuncci, MD | Scentryphar Clinical Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Itatiba | São Paulo | Brazil | |||
| Research Site |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| D015736 | Felodipine |
| C077793 | candesartan cilexetil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| UNKNOWN |
| Laboratório de Patologia Clínica Dr. Franceschi Ltda. | UNKNOWN |
| Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center | OTHER |
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| Felodipine (test) |
| Drug |
5 mg oral extended release tablet, single dose |
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| Candesartan Cilexetil | Drug | 16 mg oral tablet, single dose |
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| Felodipine | Drug | 5 mg oral extended release tablet, single dose |
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| Americana |
| Brazil |