Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-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, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-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 Hypertension
  • Focus Pharmacokinetics
  • Sponsors Bayer HealthCare
  • Most Recent Events

    • 05 Apr 2011 Actual end date (1 Mar 2011) added as reported by ClinicalTrials.gov.
    • 05 Apr 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 09 Feb 2011 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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