Trial reportDrugs in R&D2022
Chinese- and French-Manufactured Immediate-Release Glucophage
Trial report in Drugs in R&D, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03393208 (A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage Immediate Release), which is not on this map. Cited by 2 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 Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage Immediate Release (GIR) Tablets (Sino-American Shanghai Squibb Pharmaceuticals Ltd./ Manufactured in China) and 500 mg GIR Tablets (Merck Santé s.a.s. in Semoy/ Manufactured in France) Under Fed and Fasted State in Two Groups of Healthy Subjects
Who cites it
2 citing papers in PubMed, 4 citations in OpenAlex.
- Effects of Premeal Versus Postmeal Metformin Administration on Postmeal Glycemic Control in Individuals With Type 2 Diabetes Mellitus: A Randomized, 8-Week Crossover Study.Diabetes, obesity & metabolism · 2026Trial
- Harnessing Real-Time UV Imaging and Convolutional Neural Networks (CNNs): Unlocking New Opportunities for Empirical In Vitro-In Vivo Relationship Modelling.Pharmaceutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveWe aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured Glucophage
methodsThis was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time (AUC
resultsIn total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean AUC
conclusionsBioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. CLINICAL TRIALS REGISTRATION: This study was registered at ClinicalTrials.gov under the identifying number NCT03393208.
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.