Trial reportPharmacology research & perspectives2018
Tolerability, pharmacokinetics, and pharmacodynamics of mirogabalin in healthy subjects: Results from phase 1 studies.
Trial report in Pharmacology research & perspectives, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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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.
- First-In-Human Study of Mirogabalin (BM2216) Sustained-Release Tablets: Safety, Tolerability, Pharmacokinetics, Food Effect and Dose Proportionality With Comparison to Mirogabalin Besylate in Healthy Participants.Diabetes, obesity & metabolism · 2026Trial
- Bioequivalence and Comparative Pharmacokinetics of Two Generic Mirogabalin Besylate Tablets (5 mg and 10 mg) and TarligeEuropean journal of drug metabolism and pharmacokinetics · 2026Trial
- Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Mirogabalin in Healthy Chinese Participants: A Randomized, Double-Blind, Placebo-Controlled Study.Advances in therapy · 2023Trial
- Tolerability, pharmacokinetics, and pharmacodynamics of mirogabalin in healthy subjects: Results from phase 1 studies.Pharmacology research & perspectives · 2018Trial
- Coadministration of probenecid and cimetidine with mirogabalin in healthy subjects: A phase 1, randomized, open-label, drug-drug interaction study.British journal of clinical pharmacology · 2018Trial
- Therapeutic potential of combining mirogabalin with antidepressants in relieving hypersensitivity: evidence from a mouse model of neuropathic pain.Pharmacological reports : PR · 2026Article
- Quantitative analysis and method validation of mirogabalin in postmortem blood and urine using liquid chromatography-tandem mass spectrometry.Forensic toxicology · 2026Article
- Akathisia induced by concurrent use of mirogabalin and sulfamethoxazole-trimethoprim: a case report.Journal of pharmaceutical health care and sciences · 2026Article
- Platelet-rich plasma in cartilage repair: biological mechanisms and clinical perspectives.Frontiers in sports and active living · 2026Review
- Calcium Channel αPain and therapy · 2025Review
- Mirogabalin as a novel calcium channel αFrontiers in pharmacology · 2024Review
- A phase I study to evaluate the safety, tolerability, and pharmacokinetics of a novel, potent GABA analog HSK16149 in healthy Chinese subjects.Frontiers in pharmacology · 2023Article
- The Clinical Application and Progress of Mirogabalin on Neuropathic Pain as a Novel Selective Gabapentinoids.Mediators of inflammation · 2023Review
- The Evidence for Effective Inhibition ofInternational journal of molecular sciences · 2022Article
- Mirogabalin as a Novel Gabapentinoid for the Treatment of Chronic Pain Conditions: An Analysis of Current Evidence.Anesthesiology and pain medicine · 2021Review
- Mirogabalin-A Novel Selective Ligand for the α2δ Calcium Channel Subunit.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Mirogabalin: could it be the next generation gabapentin or pregabalin?The Korean journal of pain · 2021Review
- Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study.Pain and therapy · 2020Article
- Pharmacokinetics and safety after once and twice a day doses of meclizine hydrochloride administered to children with achondroplasia.PloS one · 2020Article
- Mirogabalin: First Global Approval.Drugs · 2019Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Three phase 1 pharmacokinetic (PK)/pharmacodynamics (PD) studies were conducted in healthy men and women to further characterize the safety, tolerability, and PK/PD of mirogabalin administration with or without food and to guide the dose selection and regimen for phase 2 and 3 clinical development. The 3 studies included 2 randomized, double-blind, placebo-controlled, single- and multiple-ascending-dose studies, and 1 open-label, crossover study to evaluate the PK of mirogabalin administered under fasting and fed (high-fat meal) conditions. Forty-eight and 47 healthy volunteers completed the single- and multiple-dose studies, respectively. Thirty subjects were enrolled and completed the food effect study. Mirogabalin was well tolerated in the fed and fasted states. The most frequent treatment-emergent adverse events (TEAEs)-dizziness and somnolence-were expected based on mirogabalin's mechanism of action. Subjects receiving the highest mirogabalin doses (50 and 75 mg single dose) showed greater dizziness and sedation and higher rates of TEAEs than subjects receiving 3-30 mg. After oral administration, mirogabalin was rapidly absorbed (time to maximum concentration, ∼1 hour) and eliminated through urine unchanged (61%-72% urinary excretion). Exposure increased in a dose-proportional manner after single or multiple mirogabalin doses. No significant accumulation occurred with multiple doses over 14 days. After single doses of mirogabalin (15 mg), the bioavailability was considered equivalent in the fed and fasted states, indicating that mirogabalin can be taken without food restrictions. Based on these data, mirogabalin 15 mg twice daily was selected as the highest target dose for further clinical development.
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