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A Pharmacokinetic Bridging Study to Compare Systemic Exposure to Budesonide between Budesonide Oral Suspension and ENTOCORT EC in Healthy Individuals.

Author: FinkelmanRichard D, LanLan, SongIvy H

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Eosinophilic esophagitis (EoE) is a chronic inflammatory disease that affects the esophagus. Budesonide oral suspension (BOS) is a new drug that is being developed for the treatment of EoE. BOS is a viscous, muco-adherent formulation of budesonide that is designed to stay in the esophagus for a longer period of time. This study compared the systemic exposure to budesonide from BOS with that from ENTOCORT EC, a gelatin capsule formulation of budesonide that is FDA-approved for the treatment of Crohn's disease. The study found that BOS produced lower systemic exposure to budesonide than ENTOCORT EC. This suggests that BOS may be a safer treatment option for EoE than ENTOCORT EC, as it is likely to produce fewer side effects.
Paper Details　
Original Abstract of the Article :
Currently, there are no US FDA-approved therapies for eosinophilic esophagitis (EoE). Budesonide oral suspension (BOS; SHP621, TAK-721) is a viscous, muco-adherent, oral formulation of budesonide that is in phase III development for the treatment of EoE. BOS 2 mg twice daily was studied in 12- and 3...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7691405/

データ提供：米国国立医学図書館（NLM）

Budesonide: A New Hope for Eosinophilic Esophagitis

The field of [gastrointestinal disorders] continues to search for effective treatments for conditions like eosinophilic esophagitis (EoE). This study focuses on the pharmacokinetic comparison of two different formulations of [budesonide], a medication commonly used to treat inflammatory bowel disease, for their potential application in EoE.

Pharmacokinetic Bridging: Ensuring Safety and Efficacy

The study compared the systemic exposure of budesonide from a muco-adherent, oral suspension formulation (BOS) with that from a gelatin capsule formulation (ENTOCORT EC). The goal was to establish a pharmacokinetic bridge, allowing for extrapolation of safety data from ENTOCORT EC to BOS, which is currently in phase III development for EoE. It's like comparing two camels traveling the same desert route, but using different methods of transportation, to ensure they reach their destination safely and effectively.

New Hope for EoE Treatment: Bridging the Gap

This study offers valuable insights for the development of budesonide-based treatments for EoE. By demonstrating a comparable systemic exposure between the two formulations, the researchers provide a crucial foundation for further clinical trials. It's like finding a reliable path through the desert, enabling researchers to confidently move forward with the development of a new treatment option for EoE.

Dr.Camel's Conclusion

The research on budesonide's potential for EoE treatment is like a desert oasis, promising relief for patients suffering from this challenging condition. The pharmacokinetic bridging study provides a crucial stepping stone towards the development of a safe and effective treatment option. As researchers continue their journey, we can hope for a brighter future for individuals with EoE.

Date :
  1. Date Completed 2021-02-16
  2. Date Revised 2021-10-20
Further Info :

Pubmed ID

33057953

DOI: Digital Object Identifier

PMC7691405

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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