Trial reportBMC pharmacology & toxicology2017
Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs.
Trial report in BMC pharmacology & toxicology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01344070 (Generic Formulations of Commonly-Used, Immediate-Release, Solid, Oral, Drugs in Saudi Arabia), which is not on this map. Cited by 10 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.
Generic Formulations of Commonly-Used, Immediate-Release, Solid, Oral, Drugs in Saudi Arabia: Interchangeability & Post-Marketing Quality
Who cites it
10 citing papers in PubMed.
- Chinese- and French-Manufactured Immediate-Release GlucophageDrugs in R&D · 2022Trial
- Breaking barriers: how generic drugs democratize mental health.Frontiers in pharmacology · 2025Article
- Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.BMC medical research methodology · 2024Article
- Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia.BMC research notes · 2021Article
- Pharmaceutical quality of seven brands of diclofenac tablet on the Saudi market.BMC research notes · 2020Article
- Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation.BMC research notes · 2020Article
- Pharmacokinetics and Generic Drug Switching: A Regulator's View.Clinical pharmacokinetics · 2020Article
- Authors' Reply to Nicolas: "Why Were More than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"Clinical pharmacokinetics · 2020Article
- Authors' Reply to Krebs-Brown et al. Comment on: "Why Were More Than 200 Subjects Required to Demonstrate the Bioequivalence of a New Formulation of Levothyroxine with an Old One?"Clinical pharmacokinetics · 2020Article
- A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.Frontiers in pharmacology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundThe extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale.
methodsWe assessed bioequivalence of 42 generic products of 14 immediate-release oral drugs with the highest number of generic products on the Saudi market. We conducted 14 four-sequence, randomized, crossover studies on the reference and three randomly-selected generic products of amlodipine, amoxicillin, atenolol, cephalexin, ciprofloxacin, clarithromycin, diclofenac, ibuprofen, fluconazole, metformin, metronidazole, paracetamol, omeprazole, and ranitidine. Geometric mean ratios of maximum concentration (C
resultsMean (SD) age and body-mass-index of 700 healthy volunteers (28-80/study) were 32.2 (6.2) years and 24.4 (3.2) kg/m
conclusionsOn-market generic drug products continue to be reference-bioequivalent and are bioequivalent to each other based on AUC
trial registrationClinicalTrials.gov identifier: NCT01344070 (registered April 3, 2011).
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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.