Study Phase 1

Tolerability and Multiple-Dose Pharmacokinetics of Acetaminophen (Paracetamol) At and Above the Currently Recommended Maximum Daily Dose

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT Number Not Available
  • Notebook for Primary Citation Primary Citation
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameAcetaminophenProduct NameTYLENOL®Therapeutic AreaPain, Inflammation, FeverProduct ClassNonsteroidal Anti-Inflammatory Drugs (NSAIDs)Pharmacological SubgroupN/AChemical SubgroupN/ACondition StudiedHealthy Volunteers
Sponsor Protocol Number02-161Enrollment40Data PartnerKenvue% Female50%Mean/Median Age (Years)25.3% White100%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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