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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018958-12 | EudraCT Number |
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The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.
The blood collection period for pharmacokinetics after administration was 48 h. Afterwards, subjects were discharged from the ward. A safety follow-up visit was performed approximately 7 days after the last administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine + Candesartan cilexetil | Experimental | Coadministration of single doses of nifedipine and candesartan tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil | Drug | Candesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall summary of adverse events as a measure of safety and tolarability | Overview of treatment emergent adverse events and drug related adverse events, including information on severity as well as premature termination of study participation due to adverse events. | 7 weeks |
| Safety related laboratory findings | Laboratory parameters were evaluated in terms of multiples of their upper limits of normal. Changes were considered relevant, if they were at least 1.5 times above the upper limit of normal. | 7 weeks |
| Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) (Cmax/D) | 48 hours | |
| Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity divided by dose (mg) (AUC/D) | 48 hours | |
| Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration (Cmax) | 48 hours | |
| Pharmacokinetic parameters: Area under the plasma concentration vs time curve from zero to infinity after single (first) dose (AUC) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Maximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weight (Cmax,norm) | 48 hours | |
| Pharmacokinetic parameters: Area under the curve divided by dose per kg body weight (AUCnorm) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuppertal | North Rhine-Westphalia | 42096 | Germany |
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| 48 hours |
| Pharmacokinetic parameters: AUC from time 0 to the last data point (AUC(0-tn)) | 48 hours |
| Pharmacokinetic parameters: Time to reach maximum drug concentration in plasma after single (first) (tmax) | 48 hours |
| Pharmacokinetic parameters: Half-life associated with the terminal slope (t1/2) | 48 hours |
| Pharmacokinetic parameters: Mean residence time (MRT) | 48 hours |
| Pharmacokinetic parameters: Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) (CL/f) | 48 hours |
| ID | Term |
|---|---|
| D009543 | Nifedipine |
| C077793 | candesartan cilexetil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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