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...