Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design

Trial Profile

Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan and the Loose Combination of Both Components and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Subjects Under Fed Conditions in an Open Label, Randomized, 2-way-crossover Design

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Dec 2015

At a glance

  • Drugs Candesartan cilexetil/nifedipine (Primary) ; Candesartan cilexetil; Nifedipine
  • Indications Cardiovascular disorders; Heart failure; Hypertension
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 05 Aug 2011 Actual end date (August 2011) added as reported by ClinicalTrials.gov.
    • 05 Aug 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 05 Jul 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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