Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nifedipine-candesartan FDC (BAY 98-7106)
Nifedipine-candesartan · 1 trial · 1 indication
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
AUC from time 0 to the last data point for nifedipine and candesartan
| Arm | Type | Description |
|---|---|---|
| Nifedipine-candesartan FDC | EXPERIMENTAL | Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally. |
| Nifedipine and candesartan | ACTIVE_COMPARATOR | Each subject received one dose of nifedipine GITS 60 mg and candesartan 32 mg (2 x 16 mg tablet) as loose combination, orally. |
| Nifedipine | ACTIVE_COMPARATOR | Each subject received one dose of nifedipine GITS 60 mg orally. |
| Candesartan | ACTIVE_COMPARATOR | Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally. |
| Name | Type | Description |
|---|---|---|
| Nifedipine-candesartan FDC (BAY 98-7106) | DRUG | Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan |
| Nifedipine GITS (Adalat LA, BAYA1040) | DRUG | Single oral dose of 1 tablet of nifedipine GITS 60 mg |
| Candesartan (Atacand) | DRUG | Single oral dose of 32 mg (2 x 16 mg tablet) candesartan |
Inclusion Criteria: * Healthy male subject * Age: 18 to 45 years (inclusive) at the first screening / examination visit * Ethnicity: Caucasian * Body mass index (BMI): \>/=18 and \</=29,9 kg/m² Exclusion Criteria: * Systolic blood pressure below 120 or above 145 mmHg * Diastolic blood pressure ab...
Nifedipine-candesartan is an investigational fixed dose combination of two small molecule drugs, nifedipine and candesartan, developed by Bayer AG (ticker BAYRY) as BAY 98-7106. It is being studied for essential hypertension, combining both agents in a single tablet rather than requiring separate pills.
Nifedipine-candesartan is being developed for essential hypertension, also called high blood pressure. The fixed dose combination is intended to deliver nifedipine and candesartan together in one tablet for patients whose blood pressure requires treatment with both agents.
Nifedipine-candesartan is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the fixed dose combination program, which is also identified by the code BAY 98-7106.
Nifedipine-candesartan is in Phase 1 development. It is investigational and has not been approved for marketing. The program has one completed Phase 1 trial, and no trials are currently active.
Nifedipine-candesartan has been studied in one completed Phase 1 trial, NCT01227603. That single dose bioequivalence study compared the nifedipine/candesartan fixed dose combination with a loose combination of nifedipine GITS plus candesartan and with the single components under fasting conditions. It enrolled 49 healthy male volunteers in Germany.
Yes. Nifedipine-candesartan is also known as nifedipine-candesartan FDC and by the development code BAY 98-7106. These names refer to the same Bayer fixed dose combination product containing nifedipine and candesartan.