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| Name | Class |
|---|---|
| SingHealth Investigational Medicine Unit, Singapore | UNKNOWN |
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This is an open-label, single-centre, randomized, single dose, three-way crossover, six sequence study to evaluate the comparative bioavailability of two Fixed Dose Combination (FDC) tablet formulations of amlodipine and rosuvastatin relative to innovator samples under fasting conditions, in healthy adult subjects. Subjects will be 12 Chinese and 12 Caucasian subjects living in Singapore. The randomisation will be stratified by ethnicity to ensure an equal number of subjects will be assigned to each dosing sequence. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a single 10mg amlodipine tablet and 20mg rosuvastatin tablet ; a single fixed dose combination tablet consisting of 10mg amlodipine and 20mg rosuvastatin (Test Formulation - FDC 1); and another single fixed dose combination tablet consisting of 10mg amlodipine and 20mg rosuvastatin (Test Formulation - FDC 2). Two test formulations have same active pharmaceutical ingredients (amlodipine and rosuvastatin), same doses and different inactive ingredients. Each subject will participate in three treatment periods. The study consists of a screening phase, three treatment periods and a follow-up visit. The three treatment periods will be separated by a washout period of 12-17 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Four subjects (2 Chinese and 2 Caucasian) will receive one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 1; one GSK3074477 Fixed dose combination (FDC) formulation-1 tablet in Period 2 and one GSK3074477 FDC formulation-2 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
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| Sequence 2 | Experimental | Four subjects (2 Chinese and 2 Caucasian) will receive one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 1; one GSK3074477 FDC formulation-2 tablet in Period 2 and one GSK3074477 FDC formulation-1 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
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| Sequence 3 | Experimental | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-1 tablet in Period 1, one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 2; and one GSK3074477 FDC formulation-2 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
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| Sequence 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine+Rosuvastatin | Drug | Amlodipine 10mg will be supplied as white or off-white, emerald shaped tablet. Rosuvastatin 20mg will be supplied as pink round film coated tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics (PK) parameters of amlodipine and rosuvastatin following single dose administration | PK parameters include: area under the plasma concentration curve (AUC[0-infinity], AUC[0-t]), maximum observed concentration (Cmax). | Pre dose, 15 minute [min], 30 min, 1 hour [hr], 2hr, 3hr, 4hr, 5hr, 6 hr, 8 hr, 10 hr, 12 hr, 18hr, 24hr, 36 hr, 48 hr, 72 hr and 96 hr post dose of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Additional PK parameters of amlodipine and rosuvastatin following single dose administration | PK parameters include: time to maximum observed concentration (tmax), terminal half-life (t1/2). | Pre dose, 15 minute [min], 30 min, 1 hour [hr], 2hr, 3hr, 4hr, 5hr, 6 hr, 8 hr, 10 hr, 12 hr, 18hr, 24hr, 36 hr, 48 hr, 72 hr and 96 hr post dose 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 | Singapore | 169608 | Singapore |
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| Label | URL |
|---|---|
| Results for study 200561 can be found on the GSK Clinical Study Register. | View source |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 200561 | Annotated Case Report 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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Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-1 tablet in Period 1; one GSK3074477 FDC formulation-2 tablet in Period 2; and one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
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| Sequence 5 | Experimental | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-2 tablet in Period 1; one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 2; and one GSK3074477 FDC formulation-1 tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
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| Sequence 6 | Experimental | Four subjects (2 Chinese and 2 Caucasian) will receive one GSK3074477 FDC formulation-2 tablet in Period 1; one GSK3074477 FDC formulation-1 tablet in Period 2; and one amlodipine 10mg tablet and one rosuvastatin 20mg tablet in Period 3; all treatments will be administered orally in fasted state. The three treatment periods will be separated by a washout period of between 12-17 days. |
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| GSK3074477 FDC - 1 | Drug | GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet. |
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| GSK3074477 FDC - 2 | Drug | GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet. |
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| Safety as assessed by adverse events | Up to 58 days |
| Safety as assessed by vital signs | Vital sign measurements include systolic and diastolic blood pressure, temperature, pulse rate and respiratory rate. | Up to 58 days |
| Safety as assessed by clinical laboratory safety data | Laboratory testing includes hematology, clinical chemistry and urinalysis. | Up to 58 days |
| Safety as assessed by Electrocardiogram (ECG) parameters | Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval. | Up to 58 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 200561 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200561 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200561 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200561 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200561 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200561 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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