NIH-funded research U01 cooperative agreement

Creating a new framework to evaluate how well local drugs work in the gut

Official title: Development of PBBM Framework to Support an Assessment of Bioequivalence for Locally-Acting Drugs in the Gastrointestinal Tract in Healthy Subjects and Patients

Funded at University of Bath · NIH-10701033 · Data updated 2026-11-12

This study is looking at how well different gut medications work by testing them in the lab and using computer models, so we can better understand their effectiveness for both healthy people and those with gut issues, which could help make future drug testing easier and more efficient.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Bath
NIH-funded
Lab location1 site (Bath, United Kingdom)
Project startSeptember 15, 2022
Project endAugust 31, 2025
Funding year2023
Award (this year)$295,152
NIH project number5U01FD007660-02
Project IDNIH-10701033 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates for this research include healthy individuals and patients with gastrointestinal conditions who are using or may benefit from locally acting drugs.

Less likely to help

Patients who do not have gastrointestinal conditions or are not using locally acting drugs may not receive any benefit from this research.

What this research studies

This research aims to develop a new framework for assessing the bioequivalence of locally acting drugs in the gastrointestinal tract. It combines laboratory tests (in vitro) and computer modeling (in silico) to evaluate how these drugs dissolve and are absorbed in both healthy individuals and those with gastrointestinal conditions. By analyzing existing drug products and creating new formulations, the study seeks to improve the understanding of how drug quality affects their effectiveness in the gut. This innovative approach could potentially reduce the need for extensive clinical trials in the future.

Why it matters

Potential benefit: If successful, this research could lead to more efficient evaluations of drug effectiveness, ultimately improving treatment options for patients with gastrointestinal issues.

How similar studies have gone: While the approach of integrating in vitro and in silico methods is innovative, similar methodologies have shown promise in other areas of drug evaluation, suggesting potential for success.

Where this research is happening

  • University of Bath
    Bath, United Kingdom
    Active

Researchers

  • Principal investigator: Fotaki, Nikoletta — University of Bath
  • Study coordinator: Fotaki, Nikoletta

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.