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A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects

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Trial Profile

A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2020

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At a glance

  • Drugs Ibuprofen (Primary)
  • Indications Musculoskeletal pain
  • Focus Pharmacokinetics; Proof of concept
  • Sponsors Oxford Pharmascience

Most Recent Events

  • 05 Nov 2015 Results published in an Oxford Pharmascience media release.
  • 27 Oct 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
  • 12 Aug 2015 According to an Oxford Pharmascience media release, the company has commenced dosing in the second phase of the study, in which the severity of upper GI damage will be assessed via endoscopic assessment following treatment with 2.4 g/day of ibuprofen dosed as either OXP001(2) or Brufen for 7 days. Headline results of the second phase are expected in Q4 2015, along with complete PK data and further taste masking assessments.

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