Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK2944404 FDC
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...
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GSK2944404 is an investigational small molecule fixed dose combination being developed by GSK plc for hypertension. It combines amlodipine and enalapril in a single formulation. It has completed one Phase 1 clinical trial and remains in clinical development.
GSK2944404 is being developed for the treatment of hypertension, also known as high blood pressure. It is a fixed dose combination product intended to deliver two antihypertensive agents together. The program is in Phase 1 development and is not approved for commercial use.
GSK2944404 is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program evaluating this fixed dose combination for hypertension.
GSK2944404 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
GSK2944404 has been studied in one completed Phase 1 trial, NCT01822639, titled A Fixed Dose Combination Amlodipine + Enalapril Bioavailability Study. The trial enrolled 15 healthy adult volunteers in Australia and used a controlled, randomized design without double blinding.
Yes, GSK2944404 FDC is an alternative name for GSK2944404. The FDC suffix stands for fixed dose combination, reflecting that the product combines amlodipine and enalapril in one formulation. Both names refer to the same investigational hypertension asset developed by GSK plc.