Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02075619 | Relative Bioavailability Study of One Amlodipine 10mg Tablet and One Rosuvastatin 20mg Tablet to Two Fixed Dose Combinations of Amlodipine (10mg) and Rosuvastatin (20mg) in Healthy Subjects Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Mar 24, 2014 | Jul 11, 2014 | May 10, 2017 | 1 | Singapore |
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...