Trial reportDrug design, development and therapy2021
Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects.
Trial report in Drug design, development and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 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.
A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
A Randomized, Placebo-controlled Clinical Trial Evaluating the Efficacy and Safety of Glycine and Magnesium+Thiamine Supplements, Alone or Combined, Administered for 6 Months to Patients With Primary Ciliary Dyskinesia
Who cites it
9 citing papers in PubMed, 14 citations in OpenAlex.
- Safety of benfotiamine as a Novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of benfotiamine as a source of thiamin in the context of Directive 2002/46/EC on food supplements.EFSA journal. European Food Safety Authority · 2026Article
- Glycation in Alzheimer's Disease and Type 2 Diabetes: The Prospect of Dual Drug Approaches for Therapeutic Interventions.Molecular neurobiology · 2025Review
- Upholding or Breaking the Law of Superposition in Pharmacokinetics.Biomedicines · 2024Review
- Review
- Synthetic Thioesters of Thiamine: Promising Tools for Slowing Progression of Neurodegenerative Diseases.International journal of molecular sciences · 2023Review
- Metabolism Dysregulation in Retinal Diseases and Related Therapies.Antioxidants (Basel, Switzerland) · 2022Review
- Pharmacological thiamine levels as a therapeutic approach in Alzheimer's disease.Frontiers in medicine · 2022Article
- Wernicke-Korsakoff Syndrome in a Hunger Striker Despite Oral Thiamine Supplementation.International medical case reports journal · 2022Article
- Neuroprotective Effects of Thiamine and Precursors with Higher Bioavailability: Focus on Benfotiamine and Dibenzoylthiamine.International journal of molecular sciences · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSafety, tolerability and pharmacokinetics of single and multiple ascending doses (SADs/MADs) of benfotiamine were assessed after oral administration in two randomized, double-blind, placebo-controlled, phase I trials.
methodsHealthy subjects were sequentially enrolled into one of five SAD (150-1200 mg) or three MAD (150, 300 or 600 mg) cohorts. In SAD study, each cohort of 12 subjects (n = 10, active; n = 2, placebo) were administrated once-daily doses. In MAD study, each cohort of 16 subjects (n = 12, active; n = 4, placebo) were administrated once-daily on day 1 and twice-daily on day 4-9, followed by a single morning dose on day 10.
resultsIn the SAD study, the median time to reach maximum concentration (T
conclusionBoth SAD and MAD studies of benfotiamine in healthy subjects were safe and well tolerated. TM and TDP exhibited moderate accumulation on repeated administration of benfotiamine.
Indexed as
Identifiers
What OpenQuestion holds
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.