Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
Completed
Farmacon
Phase 3
2002-12-01
The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine
iv in premature infants in the early treatment of Patent Ductus Arteriosus.
Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
Completed
Oxford Pharmascience Ltd
Phase 1
2016-12-01
This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH.
Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new
version of ibuprofen is expected to produce fewer stomach/intestine related side effects when
compared to many existing marketed formulations of Ibuprofen.
This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way
crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and
allocated interventions will be confirmed after review of data from Parts A and/or B
respectively.
A total of 30 subjects will take part in the study; 10 per study part.
The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and
without a selection of different excipients. The pharmacokinetic properties will include how
quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug
that reaches the bloodstream.
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