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ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants
Sponsor: Autobahn Therapeutics, Inc.
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.
Official title: A Phase 1, Open-Label, Randomized, Single Dose Three-Way Crossover Study to Evaluate the Bioequivalence of, and the Effect of Food on, ABX-002 in Healthy Adult Participants
Key Details
Gender
All
Age Range
19 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-01-02
Completion Date
2025-02-17
Last Updated
2026-06-17
Healthy Volunteers
Yes
Conditions
Interventions
ABX-002
ABX-002 was supplied as a solution and solid dose form.
Locations (1)
Celerion
Lincoln, Nebraska, United States