This randomized, open-label, 2-period, 2-sequence, crossover study is designed to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28, which is being developed for the treatment of lactose intolerance. The study consists of a screening visit (during the interval from Day -21 to Day -3), baseline/check-in to the clinical research unit (Day -2 to Day -1), 2 treatment periods (Day 1 and Day 3), a 48-hour washout between doses, check-out from the clinical research unit (Day 4), and 1 follow-up phone call conducted 7 to 10 days after the final dose of the study drug (i.e., during the interval from Day 10 to Day 13). The duration of subject study participation is approximately 5 weeks. Plasma samples for PK analysis will be taken at specified timepoints from 24 hours prior to each dose through 24 hours after each dose.
Randomized, open-label, 2-period, 2-sequence, crossover study to evaluate the effect of a standard meal on the pharmacokinetic (PK) profile of orally administered RP-G28.