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A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects

Trial Profile

A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Dec 2022

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At a glance

  • Drugs Cobicistat/darunavir (Primary) ; Darunavir (Primary) ; Dabigatran etexilate; Ritonavir
  • Indications HIV-1 infections
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development

Most Recent Events

  • 26 Oct 2022 Results assessing the the effect of single and repeated doses of darunavir, coad-ministered with cobicistat or ritonavir, on the pharmacokinetics ofsingle-dose dabigatran etexilate presented at the 16th International Congress on Drug Therapy and HIV Infection
  • 11 May 2021 Status changed from recruiting to completed.
  • 16 Mar 2021 Planned End Date changed from 31 Mar 2021 to 1 Apr 2021.

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