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Ibuprofen Lysinate Powder Bioequivalence study

REC reference
08/WSE04/57
Title
Ibuprofen Lysinate Powder Bioequivalence study
Contact name
Dr Salvatore Febbraro
Contact email
salvatore.febbraro@simbec.co.uk
Research summary
The purpose of this study is to compare the speed and extent of absorption into the blood stream of a new powder formulation of ibuprofen lysinate (a non-steroidal anti-inflammatory drug) with currently-licensed tablet formulations of ibuprofen (Nurofen®) and ibuprofen lysine (Nurofen Express®). This study is being conducted to provide evidence for inclusion in applications to regulatory authorities that the ibuprofen lysinate powder formulation for oral suspension is more rapidly absorbed into the blood stream than the standard ibuprofen (Nurofen®) tablets, at the same time the extent of absorption remaining the same. An ibuprofen lysine (Nurofen Express®) comparator product is being included in the design to show that the new ibuprofen lysinate powder formulation is bioequivalent (the extent of absorbtion into the blood stream is the same) to the faster absorbed lysine salt of ibuprofen.
Duration of study
3 Months
Opinion
Favourable