A fed/fasted BE study comparing Zydol vs Chiesi test tramadol product
Research type
Research Study
Full title
A randomised, 2-part single and multiple dose, crossover, open-label, bioequivalence study comparing Chiesi tramadol prolonged release capsules (TEST) with Zydol SR prolonged release tablets (REFERENCE) in normal healthy volunteers in fed and fasted states.
IRAS ID
252145
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Chiesi Ltd
Eudract number
2018-003213-17
Duration of Study in the UK
0 years, 4 months, 12 days
Research summary
This study will be investigating the bioequivalence of a test prolonged release tramadol product (developed by Chiesi) against a currently marketed Zydol prolonged release tablet in both the fed and fasted states.\n\nTramadol is a painkiller used in the management of moderate to severe pain and has been marketed worldwide for over 40 years in countries including Germany, UK, USA and Australia.\n\nThis study will involve 2 parts. Part A will be conducted in 16 subjects (male and female) and will consist of 4 treatment periods of approximately 4 days in duration, each involving administration of single 200 mg dose of either the test or reference product following a fast and consumption of a high fat breakfast.\n\nPart B will be conducted in 16 subjects (male and female) and involve 2 treatment periods of approximately 7 days duration in which subjects will take a daily dose of 200 mg of both the test and reference product (1 per period) for 4 days.\n\nThe study will investigate whether the test product is equivalent to the reference product with respect to its’ effect i.e. the amount of drug measured in the bloodstream at defined time points. Blood samples will be taken throughout the course of the study in order to measure this and the results of the test versus reference product will be compared.\n\nBy obtaining these results, Chiesi UK intend to apply for marketing authorisation for the test product (prolonged release tramadol) and subsequently market the product.
REC name
Wales REC 1
REC reference
18/WA/0275
Date of REC Opinion
3 Oct 2018
REC opinion
Further Information Favourable Opinion