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This study is designed as a Phase-I, 2-period, cross-over, randomised, open-label, single centre study to determine bioequivalence of a single 32 mg dose of the proposed commercial oral suspension of candesartan cilexetil (1 mg/mL) and a single 32 mg dose of the candesartan cilexetil oral suspension (1.6 mg/mL) used in the paediatric program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Candesartan cilexetil 1mg/mL |
|
| B | Experimental | Candesartan cilexetil 1.6mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil | Drug | Formulation:Oral suspensionStrength:1 mg/mLDose: 32 mg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK (Candesartan cilexetil) | Collected at pre-dose and at selected time points; 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30 and 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, ECG, vital signs, safety laboratory) | During the whole treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Hainer, MD | AstraZeneca | Study Director |
| Klaus Francke, Dr | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | United Kingdom |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
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| Candesartan cilexetil |
| Drug |
Formulation:Oral suspensionStrength:1.6 mg/mLDose: 32 mg, single dose |
|