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Also known as GSK3074477 FDC - 1
GSK3074477- 1 · 1 trial · 1 indication
PK parameters include: area under the plasma concentration curve (AUC\[0-infinity\], AUC\[0-t\]), maximum observed concentration (Cmax).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Sequence 4 | EXPERIMENTAL | 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| GSK3074477 FDC - 1 | DRUG | GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet. |
| GSK3074477 FDC - 2 | DRUG | GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet. |
Inclusion Criteria: * Male or female between 21 and 65 years of age inclusive, at the time of signing the informed consent. * Alanine transaminase, alkaline phosphatase and total bilirubin \<=1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated a...
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GSK3074477- 1 is an investigational small molecule fixed dose combination developed by GSK plc for hypertension. It combines amlodipine 10mg and rosuvastatin 20mg in a single tablet. It is in Phase 1 clinical development and has been studied in healthy volunteers.
GSK3074477- 1 is being developed for hypertension, a cardiovascular condition. The Phase 1 trial enrolled healthy subjects rather than patients with hypertension, so the program is at an early stage of development. No approved use has been established for this fixed dose combination.
GSK3074477- 1 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 relative bioavailability study of the amlodipine and rosuvastatin fixed dose combination conducted in Singapore.
GSK3074477- 1 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved for any indication.
GSK3074477- 1 has been evaluated in one completed Phase 1 trial, NCT02075619. The study was a controlled, randomized relative bioavailability study of one amlodipine 10mg tablet and one rosuvastatin 20mg tablet compared with two fixed dose combinations of amlodipine 10mg and rosuvastatin 20mg in 24 healthy subjects under fasting conditions in Singapore.
Yes, GSK3074477- 1 is also known as GSK3074477 FDC - 1. Both names refer to the same fixed dose combination of amlodipine 10mg and rosuvastatin 20mg developed by GSK plc for hypertension.