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A Phase 1 Open-Label, Randomized, Parallel-Group Study in Healthy Subjects to Investigate the Effect of Different Storage Conditions of a Long-Acting Nanosuspension of Rilpivirine on the Single-Dose Plasma Pharmacokinetics of Rilpivirine After Intramuscular Injection

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Trial Profile

A Phase 1 Open-Label, Randomized, Parallel-Group Study in Healthy Subjects to Investigate the Effect of Different Storage Conditions of a Long-Acting Nanosuspension of Rilpivirine on the Single-Dose Plasma Pharmacokinetics of Rilpivirine After Intramuscular Injection

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Sep 2021

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At a glance

  • Drugs Rilpivirine (Primary) ; Rilpivirine
  • Indications HIV-1 infections
  • Focus Pharmacokinetics
  • Sponsors Janssen Infectious Diseases BVBA

Most Recent Events

  • 12 Sep 2021 Results (n=986) of population pharmacokinetics of the rilpivirine long-acting from seven clinical studies (TMC278-C158 (NCT01031589), TMC278LAHTX1001(NCT02547870), TMC278LAHTX1002 (NCT03127189) and LAI115428(NCT01593046) LATTE-2 (NCT02120352) (NCT02951052) and(NCT02938520) published in the Journal of Antimicrobial Chemotherapy
  • 14 Jun 2016 Status changed from recruiting to completed.
  • 30 Sep 2015 Status changed from not yet recruiting to recruiting, as reported by ClinicalTrials.gov.

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