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Pilot Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cysteamine Bitartrate (Cystagon) in Patients With Nephropathic Cystinosis

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Trial Profile

Pilot Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cysteamine Bitartrate (Cystagon) in Patients With Nephropathic Cystinosis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Dec 2024

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At a glance

  • Drugs Mercaptamine bitartrate (Primary)
  • Indications Nephropathic cystinosis
  • Focus Adverse reactions
  • Sponsors Amgen; Raptor Pharmaceutical Inc

Most Recent Events

  • 24 Oct 2014 As per NCT record phase changed from I to I/II and primary end point changed from safety and tolerability to Pk and PD and respective time frame got decreased.
  • 26 Jun 2014 New trial record

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