Bioequivalence and pharmacokinetic comparison of two fixed dose combination of Metformin/ Glibenclamide formulations in healthy subjects under fed condition.

Author: AngJ Y, ChangC T, ChinS K, LimA B, TanS S, TanW H, WongJ M, YuenK H

Paper Details 
Original Abstract of the Article :
AIM: This study is conducted to compare the pharmacokinetic profiles of two fixed dose combination of metformin/glibenclamide tablets (500mg/5 mg per tablet). MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study w...See full text at original site
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引用元:
https://pubmed.ncbi.nlm.nih.gov/32467546

データ提供:米国国立医学図書館(NLM)

Comparing the Bioequivalence of Metformin/Glibenclamide Formulations

The field of pharmacokinetics is concerned with understanding how drugs move through the body. This study dives into the fascinating world of bioequivalence, which investigates whether two different formulations of the same drug have the same effects in the body. In this particular research, the researchers employed a crossover design, where participants received both the test and reference formulations, to compare the pharmacokinetic profiles of two fixed-dose combinations of metformin/glibenclamide tablets. Their goal was to see if the two formulations were bioequivalent, meaning they delivered the same amount of medication to the bloodstream.

Bioequivalence Confirmed: Good News for Patients

The results were positive for the test preparation, indicating that it was bioequivalent to the reference preparation. Specifically, the confidence intervals for the area under the curve (AUC) and maximum concentration (Cmax) were within the acceptable range. This means that both formulations delivered similar amounts of the drug into the bloodstream.

Safety and Side Effects: A Smooth Ride Through the Desert of Medication

The study also focused on safety and side effects. While no serious adverse events were observed, some participants experienced mild side effects, such as dizziness, diarrhea, headache, and excessive hunger. These side effects were generally mild and related to the study drugs. It's interesting to note that, just as a camel can withstand the harsh desert environment, these medications can also be tolerated by the human body, with some minor adjustments needed along the way.

Dr.Camel's Conclusion

This research provides good news for patients who are prescribed metformin/glibenclamide combinations. It confirms that different formulations of this medication are bioequivalent, ensuring that patients receive the same therapeutic effect regardless of the specific brand they are prescribed. However, it's important to remember that every individual is different, and side effects may vary. If you experience any unexpected side effects while taking this medication, it's crucial to consult your doctor.

Date :
  1. Date Completed 2021-04-26
  2. Date Revised 2021-04-26
Further Info :

Pubmed ID

32467546

DOI: Digital Object Identifier

32467546

Related Literature

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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