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...
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5/50 amlodipine/losartan is a fixed dose combination tablet containing amlodipine 5 mg and losartan 50 mg. It is being developed by GSK plc (ticker GSK) for hypertension. The combination pairs two blood pressure lowering agents in a single tablet. It is an investigational product in Phase 1 development.
5/50 amlodipine/losartan is intended for the treatment of hypertension. The fixed dose combination combines amlodipine 5 mg and losartan 50 mg in one tablet. GSK plc is developing it for this cardiovascular indication. It is not yet approved and remains in clinical development.
GSK plc, which trades under the ticker GSK, is the developer of 5/50 amlodipine/losartan. The company is advancing this fixed dose combination of amlodipine 5 mg and losartan 50 mg for hypertension. GSK sponsored the clinical trial evaluating the product.
5/50 amlodipine/losartan is in Phase 1 development. The single completed trial, NCT01797926, was a Phase 1 study. It is an investigational fixed dose combination and is not approved for marketing. No active trials are currently listed for this asset.
5/50 amlodipine/losartan has been studied in one completed Phase 1 trial, NCT01797926. The study evaluated the bioequivalence of two fixed dose combination tablet formulations, FDC5/50 and FDC5/100, under fasting conditions. It enrolled 102 healthy adult volunteers in South Africa and was controlled and randomized.