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A Phase 1, Open-Label, Single-Dose, Three-Period, Randomized Study Comparing the Pharmacokinetics of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Healthy Adult Subjects

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Trial Profile

A Phase 1, Open-Label, Single-Dose, Three-Period, Randomized Study Comparing the Pharmacokinetics of Cysteamine Bitartrate Delayed-Release Capsules Following Oral Administration with Orange Juice, Water, or Omeprazole in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Feb 2018

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At a glance

  • Drugs Mercaptamine bitartrate (Primary) ; Omeprazole
  • Indications Nephropathic cystinosis
  • Focus Pharmacokinetics
  • Sponsors Horizon Pharma

    • Most Recent Events

    • 16 Feb 2018 New trial record
    • 06 Feb 2018 Primary endpoint (Maximum observed concentration (Cmax)) has been met, according to results published in the Advances in Therapy Journal.
    • 06 Feb 2018 Primary endpoint (Area under the concentrationtime curve from time 0 extrapolated to infinity (AUC0-infinity)) has been met, according to results published in the Advances in Therapy Journal.

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