Charleston Laboratories Clinical Development Plan:
A Phase I bioequivalence study will be conducted evaluating the safety, tolerability, and pharmacokinetics of CL-108.
Investigative Sites for Charleston Laboratories' Phase III Efficacy and Safety Post-Operative Pain Study
Arrangements are being finalized with major universities in the United States to conduct the pivotal Phase III trial. The clinical investigators at these sites bring to the conduct of this trial the proven (and FDA-approved) expertise of
their research units. Additionally, the physicians themselves augment
Charleston Laboratories' clinical development program by their stature as
pain experts, their upstanding reputation and respect at FDA, and their
impressive lists of publications in prominent scientific journals.
