Publications by authors named "Tricia Braun"
Article Synopsis
- Recurrent Clostridioides difficile infection causes significant health issues in the U.S., and RBX2660, a live biotherapeutic made from human stool, is being researched to reduce these infections.
- In a phase III clinical trial, adults with prior C. difficile infections were randomly given either RBX2660 or a placebo, focusing on the absence of infection symptoms within eight weeks as the main success measure.
- Results showed RBX2660 had a treatment success rate of 70.6% compared to 57.5% for placebo, and while it was generally well tolerated, it had a slightly higher incidence of mild gastrointestinal side effects.
Objective: Evaluate the pharmacokinetics (PK), safety, and tolerability of single doses of once-daily USL255, Qudexy XR (topiramate) extended-release capsules, over a wide dosing range.
Methods: Two single-dose, phase I studies in healthy adults were used to evaluate the PK profile and maximum tolerated dose (MTD) of USL255 from 25-1,400 mg. Standard PK parameters assessed included area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax ).
Purpose: Compare the pharmacokinetic (PK) profiles of immediate- and extended-release formulations of topiramate (TPM) in healthy subjects following multiple dosing, and evaluate maintenance of topiramate exposures after switching formulations.
Methods: A randomized, open-label, single-center, two-way crossover, multiple-dose study comparing the steady-state PK profile of once-daily extended-release topiramate (USL255) to immediate-release topiramate (TPM-IR) administered twice-daily. The TPM PK profile was evaluated using standard PK parameters (e.