Trial reportEuropean journal of drug metabolism and pharmacokinetics2026
Bioequivalence and Comparative Pharmacokinetics of Two Generic Mirogabalin Besylate Tablets (5 mg and 10 mg) and Tarlige
Trial report in European journal of drug metabolism and pharmacokinetics, 2026. 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
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
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveMirogabalin besylate is a selective α2δ-1 ligand approved for diabetic peripheral neuropathic pain. This study evaluated the pharmacokinetic (PK) bioequivalence and safety of generic 5 mg and 10 mg mirogabalin formulations compared with the reference product (Tarlige
methodsThis pooled analysis comprised two independent, randomized, open-label, two-period crossover trials: one evaluating the 5 mg formulation (24 participants/group) and another evaluating the 10 mg formulation (36 participants/group). Liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays have been validated over ranges of 1.00-200 ng/mL (5-mg study) and 0.50-500 ng/mL (10-mg study) for plasma mirogabalin quantification. Primary endpoints were peak plasma concentration (C
resultsFor the 5 mg formulation, the fasting study demonstrated bioequivalence with a C
conclusionsBoth generic formulations met bioequivalence criteria to Tarlige TRIAL REGISTRATION NO: ( http://www.chinadrugtrials.org.cn ): 5 mg: CTR20232783; 10 mg: CTR20242717.
Indexed as
Identifiers
41642563What 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.