An open-label,randomized, single-dose, two-treatment, two-sequence,three-period, replicate crossover study to determine the bioequivalence of SPP100 (aliskiren) 300mg tablets (small tablet vs.marketed formulation) in healthy adult subjects under light meal conditions

Trial Profile

An open-label,randomized, single-dose, two-treatment, two-sequence,three-period, replicate crossover study to determine the bioequivalence of SPP100 (aliskiren) 300mg tablets (small tablet vs.marketed formulation) in healthy adult subjects under light meal conditions

Completed
Phase of Trial: Phase I

Latest Information Update: 31 Aug 2016

At a glance

  • Drugs Aliskiren (Primary)
  • Indications Hypertension
  • Focus Pharmacokinetics
  • Sponsors Novartis
  • Most Recent Events

    • 14 May 2012 New trial record
    • 30 Apr 2012 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India
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