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www.fdanews.com/articles/69806-equitech-announces-further-trial-results-for-its-new-ibuprofen-caplet

EquiTech Announces Further Trial Results for its New Ibuprofen Caplet

March 14, 2005

EquiTech has announced further details of its Phase II clinical trial of ZAG-1701, its novel reformulated ibuprofen caplet, following a review of the results of the clinical trial conducted by Analgesic Development of New York.

The primary objective of the study was to compare the speed of absorption of ibuprofen into the bloodstream of a 400-mg dose of ZAG-1701 with a 400-mg dose of Motrin IB in patients experiencing the pain of wisdom-tooth extraction. This study was undertaken because previous work done by EquiTech scientists suggested that patients in pain absorb drugs more slowly compared to healthy subjects not in pain.

The data from the clinical study revealed that at 15 minutes after drug dosing, 2.8 times more ibuprofen entered the bloodstream in patients who took ZAG-1701 compared to patients who took Motrin IB. Statistically significant increased absorption was also observed at 30 minutes, 45 minutes and 60 minutes where 2.7, 2.3 and 2 times more ibuprofen entered the bloodstream in patients given ZAG-1701 compared to patients who took Motrin IB, respectively.

The data also showed that in patients who received ZAG-1701 caplets, peak concentrations of ibuprofen in the bloodstream occurred on average at one hour and 26 minutes compared to two hours and 19 minutes for Motrin IB.