Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
5/50 amlodipine/ losartan · 1 trial · 1 indication
Pharmacokinetic (PK) parameters for amlodipine and losartan will include the 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), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time exposure over the dosing and interval area under the plasma concentration time curve (AUC (0- infinity)), and maximum plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Group 1 (5 mg amlodipine and 50 mg losartan) | EXPERIMENTAL | Subjects in Group 1 will be randomized to receive a single dose FDC 5/50 mg tablet and also separate single tablets each of reference treatment 5 mg amlodipine and 50 mg losartan. The reference treatment will be replicated in a three sequence, three period design |
| Group 2 (5 mg amlodipine and 100 mg losartan) | EXPERIMENTAL | Subjects in Group 2 will be randomized to receive a single dose FDC 5/100 mg; and also separate single tablets each of reference treatment 5 mg amlodipine and 100 mg losartan. The reference treatment will be replicated in a three sequence, three period design |
| Name | Type | Description |
|---|---|---|
| Reference Treatment: 5 mg amlodipine + 50 mg losartan | DRUG | Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 50 mg losartan tablet administered orally in fasted state as a single dose |
| Reference Treatment:5 mg amlodipine + 100 mg losartan | DRUG | Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 100 mg losartan tablet administered orally in fasted state as a single dose |
| FDC 5/50 amlodipine/ losartan | DRUG | Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 50 mg losartan in fasted state |
| FDC 5/100 amlodipine /losartan | DRUG | Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 100 mg losartan in fasted state |
Inclusion Criteria: * Age \& Gender: Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Body weight \>= 50 kg and body mass index (BMI) within the range 18.5 to 24.9 kilogram/meter squared. * Alanine aminotransferase (ALT) alkaline phosphatase an...
5/50 amlodipine/losartan is a fixed-dose combination of amlodipine and losartan being developed for the treatment of hypertension. It is a small molecule cardiovascular therapy currently in Phase 1 clinical development.
5/50 amlodipine/losartan is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate this fixed-dose combination for hypertension.
5/50 amlodipine/losartan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
5/50 amlodipine/losartan has one completed clinical trial, NCT01797926, which studied the bioequivalence of two fixed-dose combination tablet formulations under fasting conditions. The trial enrolled 102 participants in South Africa and included healthy volunteers.
5/50 amlodipine/losartan is a fixed-dose combination product containing both amlodipine and losartan in a single tablet. It is being developed to provide the combined effects of both medications for hypertension treatment.