Bioequivalence of OTR and oxycodone in HV with food effect
Research type
Research Study
Full title
A randomised, open-label, 2-part, 4-cohort single-dose, crossover study in healthy volunteers to assess the bioequivalence of OTR tablet 10 mg with oxycodone prolonged release tablet 10 mg in two cohorts (fed and fasted), and OTR tablet 80 mg with oxycodone prolonged release tablet 80 mg in two cohorts (fed and fasted)
IRAS ID
247283
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Mundipharma Research Ltd.
Eudract number
2017-003000-52
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
OxyContin is a marketed prolonged release, oral preparation of oxycodone used for the treatment of moderate to severe malignant and non-malignant pain. It is a semi-synthetic opioid which acts primarily as an analgesic. \n\nThis study is designed to assess whether the absorption and availability of two currently marketed OxyContin preparations is equivalent. The study will compare the US (OTR US) and the UK formulation (OXC EU) of OxyContin at the 10mg and 80mg dose strengths, in the fed and fasted states. \nThis study is an open label, crossover study in which 104 healthy male and female volunteers will be randomised, with the aim of 84 participants completing both parts and providing valid pharmacokinetic data. \nSubjects will attend a screening visit within a 21 day period prior to admission. Subjects who meet all eligibility criteria will attend for a 2 night admission on two occasions, one for each study part.\nSubjects will be randomised to one of 4 cohorts (10mg fed, 10mg fasted, 80mg fed, 80mg fasted) and to one of the 2 sequences within the cohort (OTR US first, OXC EU first) and will receive a single dose of IMP on the morning of Day 1 of each study period. Subjects will undergo blood sampling for PK and safety assessments up to 36 hours post-dose and will be discharged from the study unit on the evening of Day 2. There will be a minimum of 7 days between dosing in each study period. \nIn order to counteract the effects of OxyContin, naltrexone will be administered pre and post dose. Naltrexone is a competitive antagonist at the opioid receptor and blocks the effects of opioids. It does not affect the pharmacokinetics of OxyContin.\nSubjects will attend for a post-study follow up 7-10 days after last dosing.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0824
Date of REC Opinion
1 Jun 2018
REC opinion
Favourable Opinion