A Phase 1 interventional study of Nifedipine/Candesartan (BAY 98-7106) and Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333) in Hypertension, Essential, sponsored by Bayer. Completed at 1 site in Germany. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-10.
Sponsored by Bayer · Phase 1 and Interventional
Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the corresponding loose combination under fed conditions.
Clinical pharmacology
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 49 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Use of medication within 4 weeks prior to the first study drug administration which could interfere with the investigational products (e.g. CYP3A inhibitors or CYP3A inducers)
At the first screening visit
Drug: Nifedipine/Candesartan (BAY 98-7106)
Drug: Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
Cmax
Maximum drug concentration in plasma after dose administration for nifedipine and candesartan
Time frame: within 48 hours after each dosing
AUC(0-tlast)
Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartan
Time frame: within 48 hours after each dosing
AUC
Area under the curve from time 0 to infinity after single dose for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
Cmax,norm
Dose normalized Cmax for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
AUCnorm
AUC normalized for dose and body weight for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
AUC(0-48)
Area under the plasma concentration-time curve from time zero to 48h for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
Tmax
The time of the maximum concentration for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
t1/2
Half-life for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
MRT
The mean residence time for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
CL/F
Oral plasma clearances for nifedipine and candesartan
Time frame: Within 48 hours after each dosing
Number of participants with adverse events
Time frame: Approximately 3-7 weeks per subject
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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