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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01822639 | A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study | PHASE1 | COMPLETED | 15 | — | — | Apr 3, 2013 | May 24, 2013 | Jun 5, 2017 | 1 | Australia |
PK parameters include: maximum observed concentration (Cmax) of amlodipine and enalapril in all treatments, area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC\[0-t\]), and area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-infinity\]. Bioavailability is defined as the amount of drug available at the site of action after administration.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Subjects in this arm will receive Treatment A in period 1 and Treatment B in period 2. Treatment A is co-administration of 5mg amlodipine tablet and 20 mg enalapril maleate tablet. Treatment B (GSK2944404) is fixed dose combination tablet of 5 mg amlodipine and 20 mg enalapril. |
| Sequence 2 | EXPERIMENTAL | Subjects in this arm will receive Treatment B in period 1 and Treatment A in period 2. Treatment A is co-administration of 5mg amlodipine tablet and 20 mg enalapril maleate tablet. Treatment B (GSK2944404) is fixed dose combination tablet of 5 mg amlodipine and 20 mg enalapril. |
| Name | Type | Description |
|---|---|---|
| GSK2944404 FDC | DRUG | Uncoated, round, yellow white bilayer fixed dose combination tablet containing 5 mg amlodipine and 20 mg enalapril for single dose oral administration in each period. |
| Amlodipine 5 mg | DRUG | Emerald-shaped white 5 mg amlodipine table for single dose oral co-administration with enalapril maleate tablet in each period. |
| Enalapril Maleate 20 mg | DRUG | Peach triangle shaped 20 mg enalapril maleate tablet for single dose oral co-administration with amlodipine in each period. |
Inclusion Criteria * Male or female aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and car...