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Pharmacokinetics, Bioequivalence, and Safety Studies of Prucalopride in Healthy Chinese Subjects.

Author: ChenHuafang, HuangXiaoxiao, WangChenxiang, XiaYan, YuChao, YuXuben, ZhangDongchuan, ZhangXiuhua, ZhengXuyong, ZhouZiye

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.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This study evaluated the bioequivalence of two different formulations of prucalopride, a medication used to treat constipation. The researchers found that the generic and branded versions of prucalopride had similar pharmacokinetic profiles and safety profiles.
Paper Details　
Original Abstract of the Article :
The objectives of the present study were to evaluate the bioequivalence of 2 tablet formulations of prucalopride, generic and branded, and to investigate relevant pharmacokinetic and safety profiles. This study was designed as a randomized, open-label, fasting, single-dose, crossover, and dual-perio...See full text at original site
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引用元：
https://doi.org/10.1002/cpdd.754

データ提供：米国国立医学図書館（NLM）

Bioequivalence and Safety Studies of Prucalopride in Healthy Chinese Subjects

This study investigates the bioequivalence and safety of two tablet formulations of prucalopride, a medication used to treat constipation. The researchers conducted a randomized, open-label, single-dose, crossover study with 12 healthy Chinese subjects. They compared the pharmacokinetic profiles of generic and branded prucalopride tablets, measuring plasma concentrations of the drug after administration. The findings indicated that the two formulations were bioequivalent, showing similar pharmacokinetic profiles and safety profiles. No significant differences were observed between the two formulations in terms of absorption, distribution, metabolism, or excretion.

Ensuring Safe and Effective Medication Use

This study provides reassuring evidence regarding the bioequivalence and safety of generic prucalopride tablets compared to the branded formulation. The findings contribute to ensuring the availability of safe and effective generic medications for patients, ultimately promoting access to affordable healthcare.

Navigating the World of Generics

The landscape of pharmaceuticals is often characterized by the availability of generic drugs, providing more affordable alternatives to branded medications. This study demonstrates the importance of rigorous bioequivalence testing to ensure that generic formulations are comparable to their branded counterparts in terms of safety and effectiveness. It's a testament to the ongoing efforts to ensure that patients have access to high-quality and affordable medications.

Dr.Camel's Conclusion

This study confirms the bioequivalence and safety of generic prucalopride tablets, offering a valuable contribution to the availability of affordable and effective treatment options for constipation. The research underscores the importance of rigorous scientific testing to ensure the quality and safety of generic medications, fostering trust in the healthcare system and promoting access to affordable healthcare for all.

Date :
  1. Date Completed 2021-08-12
  2. Date Revised 2022-12-07
Further Info :

Pubmed ID

31797570

DOI: Digital Object Identifier

10.1002/cpdd.754

Related Literature

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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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