A bioequivalence paracetamol and codeine comparison study
Research type
Research Study
Full title
A randomised, open-label, three-treatment, single dose, crossover study investigating the bioequivalence of co-codamol 15/500mg capsules with a co-codamol 30/500mg tablet in healthy subjects under fasting conditions.\n
IRAS ID
162008
Contact name
Ms Patricia McKee
Contact email
Sponsor organisation
Galen Ltd
Eudract number
2014-003334-12
Clinicaltrials.gov Identifier
Research summary
This is a randomised, open-label, three-treatment, single dose, crossover, bioequivalence study to compare a new strength combination drug product produced by one company with another already marketed combination drug product containing same active ingredients to see if there are differences in how much each drug is taken up by the body and how quickly.\n\nVolunteers will check into the study unit on Day -1 and will remain until check-out on Day 3, at least 48 hours after study drug administration. Study drug administration will occur on the morning of Day 1. There will be a minimum 7 day wash out period between study drug administration in each period. A post study medical will be performed 4 to 7 days after the last study drug administration.\n\nThe study duration for individual volunteers will be approximately 23 days (excluding the 28 day screening period). Duration is from Day -1 to the post study physical. The duration assumes a 7 day wash out between each study drug administration, if the wash out is longer than 7 days the total study duration will increase accordingly.\n\nVolunteers will be randomised to receive a single oral dose of study drug (Treatment 1, Treatment 2 or Treatment 3) on Day 1 of each study period in a fasted state. Over the three periods, each volunteer will receive all three treatments in an order according to the randomisation schedule.\n\nThe study is a bioequivalence study comparing the bioequivalence of drug A and drug B for the test and reference product as follows:\n\n• Drug A bioequivalence will be determined from: Treatment 1 compared with Treatment 3.\n\n• Drug B bioequivalence will be determined from: Treatment 2 compared with Treatment 3.\n\n42 healthy adult male and female volunteers aged 18 – 45 years will be randomised for this study.
REC name
HSC REC A
REC reference
14/NI/1070
Date of REC Opinion
3 Sep 2014
REC opinion
Further Information Favourable Opinion