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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021966-31 | EudraCT Number |
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Randomized, open label, single dose, 4-way crossover study to investigate the bioequivalence of a new fixed dose combination tablet of nifedipine GITS and candesartan with the corresponding loose combination and to compare it with the individual drugs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nifedipine-candesartan FDC | Experimental | Each subject received single fixed dose combination of 60 mg nifedipine and 32 mg candesartan orally. |
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| 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. |
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| Nifedipine | Active Comparator | Each subject received one dose of nifedipine GITS 60 mg orally. |
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| Candesartan | Active Comparator | Each subject received one dose of candesartan 32 mg (2 x 16 mg tablet), orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine-candesartan FDC (BAY 98-7106) | Drug | Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum drug concentration in plasma after dose administration for nifedipine and candesartan | Within 48 hours after each treatment |
| AUC(0-tn) | AUC from time 0 to the last data point for nifedipine and candesartan | Within 48 hours after each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the plasma concentration vs time curve from zero to infinity after single (first) dose for nifedipine and candesartan | Within 48 hours after each treatment |
| Cmax,norm | Maximum drug concentration in plasma after dose administration divided by dose (mg) per kg body weight for nifedipine and candesartan |
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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 |
|---|---|---|---|---|---|---|
| Cologne | North Rhine-Westphalia | 51063 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23849325 | Result | Brendel E, Weimann B, Dietrich H, Froede C, Thomas D. Investigation of bioequivalence of a new fixed-dose combination of nifedipine and candesartan with the corresponding loose combination as well as the drug-drug interaction potential between both drugs under fasting conditions. Int J Clin Pharmacol Ther. 2013 Sep;51(9):753-62. doi: 10.5414/CP201879. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| Nifedipine GITS (Adalat LA, BAYA1040) | Drug | Single oral dose of 1 tablet of nifedipine GITS 60 mg |
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| Candesartan (Atacand) | Drug | Single oral dose of 32 mg (2 x 16 mg tablet) candesartan |
|
| Within 48 hours after each treatment |
| AUCnorm | Area under the curve divided by dose per kg body weight for nifedipine and candesartan | Within 48 hours after each treatment |
| AUC(0-48) | AUC from time 0 to time 48 h for nifedipine and candesartan | Within 48 hours after each treatment |
| tmax | Time to reach maximum drug concentration in plasma after single (first) dose for nifedipine and candesartan | Within 48 hours after each treatment |
| t½ | Half-life associated with the terminal slope for nifedipine and candesartan | Within 48 hours after each treatment |
| MRT | Mean residence time for nifedipine and candesartan | Within 48 hours after each treatment |
| CL/f | Total body clearance of drug from plasma calculated after oral administration (apparent oral clearance) for nifedipine and candesartan | Within 48 hours after each treatment |
| Number of participants with adverse events | Approximately 3.5 months |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| C081643 | candesartan |
| C077793 | candesartan cilexetil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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