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This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference candesartan cilexetil (ATACANDâ„¢); the treatment periods will be separated by a washout period of at least 7 days and no greater than 14 days. This study aims to determine the relative bioavailability of a 16mg test formulation tablet of candesartan cilexetil (GW615775) compared to an 16mg reference tablet of candesartan cilexetil in healthy adult subjects. ATACAND is a registered trademark of the Astra/Zeneca group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 reference then test | Experimental | Subjects will be randomized and receive the following two treatments administered orally in a fasting state: A=Single dose of candesartan cilexetil (Reference treatment) 16mg; B= Single dose of candesartan cilexetil (Test formulation) 16mg. The two treatment periods will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Arm 2 test then reference | Experimental | Subjects will receive the following two treatments administered orally in a fasting state: A= Single dose of candesartan cilexetil (Test formulation) 16mg. B=Single dose of candesartan cilexetil (Reference treatment) 16mg. The two treatment periods will be separated by a washout period of at least 7 days and no more than 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan cilexetil (GW615775, Test formulation) | Drug | Test formulation candesartan cilexetil 16 mg will be supplied as round, biconvex white tablets with PX 16 embossed in one face and scored in the other face. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic (PK) parameters assessed by Cmax, AUC(0-infinity) and AUC(0-t) | PK parameters include: Maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0 infinity]) and area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments [AUC(0 t)]. | Pre-dose, 0.5 hour (hr), 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr of each treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters assessed by tmax, %AUCex and t1/2 | PK parameters include: Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2). | Pre dose, 0.5 hr, 1 hr, 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 5.5 hr, 6 hr, 7 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr of each treatment period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hyderabad | 500 013 | India |
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| Label | URL |
|---|---|
| Results for study 201011 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 201011 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 (Reference treatment) | Drug | Reference treatment of candesartan cilexetil 16 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (016 embossment in the plain face and A CH in the scored face). |
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| Safety and tolerability assessment as assessed by adverse events (AEs) | Up to 35 days |
| Safety and tolerability assessment as assessed by vital signs | Vital sign measurements will include systolic and diastolic blood pressure, and pulse rate. | Up to 35 days |
| Safety and tolerability assessment as assessed by clinical laboratory values | Clinical laboratory assessments will include hematology, clinical chemistry, routine urinalysis and additional parameters. | Up to 35 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 201011 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201011 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201011 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201011 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201011 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 201011 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |