BE study of Nefopam and Acupan®
Research type
Research Study
Full title
A randomised, open-label, single dose, crossover study investigating the bioequivalence of Nefopam Hydrochloride 30mg Tablets with Acupan® 30mg Tablets in healthy subjects under fasting conditions.
IRAS ID
189359
Contact name
Patricia McKee
Contact email
Sponsor organisation
Galen Ltd
Eudract number
2015-003810-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 0 months, 29 days
Research summary
This is a randomised, open-label, single dose, crossover, bioequivalence study to compare a new tablet formulation of a drug with another tablet containing the same active ingredient, currently on the market in the UK. The study will look to see how the body processes the drug and see if there are any differences between the study drug and the approved marketed reference drug.\n\nVolunteers will be randomised to receive a single oral dose of study drug or of the reference drug (Treatment 1, or Treatment 2) on Day 1 of each study period in a fasted state. Over the course of the two study periods, each volunteer will receive both treatments according to the randomisation schedule. \n\nVolunteers will check into the study 1 day prior to being administered one of the drugs. They will be fasted prior to the drug being given, for a period of at least 8 hours and fasted for 4 hours after. They will remain in the study clinic until checkout 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 10 days after the last study drug administration.\n\n\nThe study duration for individual volunteers will be approximately 18 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\n30 healthy adult male and female volunteers will be randomised for this study.
REC name
HSC REC A
REC reference
15/NI/0191
Date of REC Opinion
8 Oct 2015
REC opinion
Further Information Favourable Opinion