ArticleHeliyon2023
Bioequivalence studies of cetirizine tablets using the urine excretion data of healthy Ghanaian male volunteers.
Article in Heliyon, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
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Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: In the wake of economic challenges, the role of generic medicines has become crucial in meeting the healthcare needs of people. Their use, however, can only be guaranteed if established to be bioequivalent to their corresponding innovator products. Aim: In this study, we assess the suitability of a generic brand of cetirizine hydrochloride tablet to be used in place of the innovator brand on the Ghanaian market through bioequivalence assessment. Method: An HPLC bioanalytical method was developed and validated for the detection and quantitation of cetirizine in a urine matrix. This was then used to quantify the amount of cetirizine excreted unchanged in urine samples of 12 healthy male volunteers collected over a 24-h period using a two-way crossover design approach. Results: Chromatographic separation was successfully achieved with an isocratic elution on a reverse-phase column. The mean retention time for cetirizine was 2.890 ± 0.243 min. The mean cumulative amounts of cetirizine in the reference and test drugs excreted were 5.69 ± 0.98 mg and 5.82 ± 1.96 mg respectively. Other pharmacokinetic parameters including mean relative Areas Under Curve (AUC Conclusion: The locally manufactured test Cetirizine drug was found to be bioequivalent with the innovator brand and could serve as a suitable alternative to the latter. Additionally, relevant pharmacokinetic parameters for cetirizine has been established using urinary excretion data.
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