check_circleStudy Completed
Hypertension, Essential
Bayer Identifier:
14028
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Pivotal bioequivalence FDC nifedipine / candesartan vs. loose combination of single components, fed
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
49Trial Dates
April 2011 - September 2011Phase
Phase 1Could I Receive a placebo
NoProducts
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer Pharma AG | Berlin, 13353, Germany |
Primary Outcome
- CmaxMaximum drug concentration in plasma after dose administration for nifedipine and candesartandate_rangeTime Frame:within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- AUC(0-tlast)Area under the drug-concentration vs. time curve from time 0 to the last data point for nifedipine and candesartandate_rangeTime Frame:within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
Secondary Outcome
- AUCArea under the curve from time 0 to infinity after single dose for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- Cmax,normDose normalized Cmax for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- AUCnormAUC normalized for dose and body weight for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- AUC(0-48)Area under the plasma concentration–time curve from time zero to 48h for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- TmaxThe time of the maximum concentration for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- t1/2Half-life for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- MRTThe mean residence time for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- CL/FOral plasma clearances for nifedipine and candesartandate_rangeTime Frame:Within 48 hours after each dosingenhanced_encryptionNoSafety Issue:
- Number of participants with adverse eventsdate_rangeTime Frame:Approximately 3-7 weeks per subjectenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2Additional Information
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