Klaria Announces Successful Outcome of Pivotal Bioequivalence Study with Sumatriptan Alginate Film
Klaria reports that Sumatriptan Alginate Film has demonstrated bioequivalence to both of the US and EU approved comparator sumatriptan nasal spray products. Moreover, the clinical trial data show that Sumatriptan Alginate Film has demonstrated a lower inter-subject variability than either the US or EU sumatriptan nasal spray.The bioequivalence study was conducted in the United Kingdom. The first subject was dosed in December 2020 and the last subject was dosed in March 2021. A total of 60 subjects were recruited into the randomized, 3-way cross-over study. A total of 59 subjects