Trial reportBritish journal of clinical pharmacology2009
Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers.
Trial report in British journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
21 citing papers in PubMed, 64 citations in OpenAlex.
- Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs.BMC pharmacology & toxicology · 2017Trial
- Effect of MMX® mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials.Drug design, development and therapy · 2014Trial
- Bioequivalence of generic and branded amoxicillin capsules in healthy human volunteers.Indian journal of pharmacologyTrial
- Synergistic activity of fosfomycin and flucloxacillin against methicillin-susceptible and methicillin-resistant Staphylococcus aureus: in vitro and in vivo assessment.Medical microbiology and immunology · 2025Article
- Article
- The impact of the Sri Lankan economic crisis on medication adherence: An online cross-sectional survey.Dialogues in health · 2023Article
- Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis.Antibiotics (Basel, Switzerland) · 2023Review
- Intradiscal pharmacokinetics of oral antibiotics to treat Chronic Lower Back Pain.npj antimicrobials and resistance · 2023Review
- Review
- Comparison of Antimycotic Activity of Originator and Generics of Voriconazole and Anidulafungin against Clinical Isolates ofJournal of fungi (Basel, Switzerland) · 2022Article
- Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs.Drug safety · 2018Article
- Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.Clinical pharmacology and therapeutics · 2018Article
- Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).Clinical drug investigation · 2017Article
- Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.Pharmacotherapy · 2017Article
- Evaluation of formulation properties and skin penetration in the same additive-containing formulation.Results in pharma sciences · 2014Article
- Comparative pharmacokinetic and pharmacodynamic evaluation of branded and generic formulations of meloxicam in healthy male volunteers.Therapeutics and clinical risk management · 2013Article
- What do prescribers think of biosimilars?Targeted oncology · 2012Review
- "Ten Commandments" for the Appropriate use of Antibiotics by the Practicing Physician in an Outpatient Setting.Frontiers in microbiology · 2011Article
- The failure to show bioequivalence is not evidence against generics.British journal of clinical pharmacology · 2010Article
- Healthy volunteers and early phases of clinical experimentation.European journal of clinical pharmacology · 2010Review
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThere are concerns about the quality of generic drugs in the postmarketing setting. The aim was to establish whether two generic formulations of amoxicillin, available on the Italian market, fulfil the criteria for clinical pharmacokinetic bioequivalence vs. the branded drug.
methodsTwo generic amoxicillin products (generic A and B) were selected among four fast-release tablet formulations available on the Italian market. Twenty-four healthy adult volunteers of either sex participated to a single-dose, randomized, three-treatment, crossover, single-blind bioequivalence study designed to compare generic A and B with branded amoxicillin. Plasma samples were collected at preset times for 24 h after dosing, and assayed for amoxicillin levels by high-performance liquid chromatography.
resultsNinety percent confidence intervals of AUC ratios were 0.8238, 1.0502 (ratio 0.9302) and 0.8116, 1.1007 (ratio 0.9452) for generic A and B vs. branded amoxicillin, respectively. Ninety percent confidence intervals of C(max) ratios were 0.7921, 1.0134 (ratio 0.8960) and 0.8246, 1.1199 (ratio 0.9610) for generic A and B vs. branded amoxicillin, respectively. The mean pharmacokinetic profiles showed that the AUC value of branded amoxicillin was 8.5 and 5.4% greater than that estimated for generic A and B, respectively. Few adverse events were recorded; these were not serious and occurred without apparent relationship to any specific amoxicillin formulation.
conclusionsThese results indicate that one of the two marketed amoxicillin generics analysed in the present study is not bioequivalent to the brand leader product for C(max) on the basis of single-dose pharmacokinetic assessment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.