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A prospective, phase I, open-label, single-center, two-period, fixed-sequence study analysing effect of ribociclib on the PK of midazolam and caffeine in healthy volunteers

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Trial Profile

A prospective, phase I, open-label, single-center, two-period, fixed-sequence study analysing effect of ribociclib on the PK of midazolam and caffeine in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Jul 2020

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At a glance

  • Drugs Ribociclib (Primary) ; Caffeine; Midazolam
  • Indications Breast cancer; Liposarcoma; Ovarian cancer; Pancreatic cancer; Precursor B-cell lymphoblastic leukaemia-lymphoma; Solid tumours; Squamous cell cancer
  • Focus Pharmacokinetics

Most Recent Events

  • 08 Jul 2020 New trial record
  • 18 Jun 2020 Results performing Ribociclib Drug-Drug Interactions and Clinical Evaluations of PBPK Modeling to Guide Drug Labeling, published in the Clinical Pharmacology and Therapeutics

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