Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2944404 · 1 trial · 1 indication
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...
GSK2944404 is an investigational small molecule being developed for the treatment of hypertension, a cardiovascular condition characterized by elevated blood pressure. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GSK2944404 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug.
GSK2944404 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for use in any country. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.
GSK2944404 has been studied in one completed Phase 1 clinical trial, identified as NCT01822639. This trial, titled 'A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study,' enrolled 15 participants in Australia and evaluated the drug in healthy volunteers.
GSK2944404 is not the same as amlodipine or enalapril. The completed clinical trial NCT01822639 was a bioavailability study of a fixed-dose combination of amlodipine and enalapril, but GSK2944404 is a distinct investigational drug being developed for hypertension.