U.S., June 18 -- ClinicalTrials.gov registry received information related to the study (NCT07652697) titled 'ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants' on May 29.
Brief Summary: The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the new solid formulation of ABX-002.This study design is consistent with FDA guidelines for the assessment of BE.
This was an open label, randomized, single dose, three-way crossover BE and food-effect study. Therefore, the total number of participants in this study was 18.
Study Start Date: Jan. 02, 2025
...