Drugs R D. 2026 Jul 1. doi: 10.1007/s40268-026-00547-8. Online ahead of print.
ABSTRACT
BACKGROUND: Gabapentin is effective for treating post-herpetic neuralgia and neuropathic pain by stabilizing nerve activity through blocking calcium channels and reducing neurotransmitter release. Gabapentin is available in immediate-release (IR) and extended-release (ER) formulations. A comparative bioavailability study was conducted between Gabapentin ER 600 mg tablets once-daily (OD) (Gabantin® GRS) [Test (T)] (manufactured by Sun Pharmaceuticals Industries Limited), and Gabapentin Tablets 600 mg OD (Gralise®) [Reference (R)] (distributed by Almatica Pharma LLC) in healthy human male adults under fed conditions.
METHODS: In this open-label, balanced, randomized, crossover study each subject received a 600 mg single dose of either T or R in Period 1, followed by crossover treatment in Period 2, with a washout period of 12 days in-between. Pharmacokinetic parameters, including Cmax, AUC0-t, and AUC0₋∞, were assessed. Safety was monitored through treatment-emergent adverse events (AEs).
RESULTS: All 24 enrolled subjects completed the study. The test formulation demonstrated comparable pharmacokinetic profile to the reference product, meeting the criteria for bioequivalence within acceptable limits (0.80-1.25). The percentage ratio for T vs R product was 0.9171 (90% confidence interval [CI] 0.826-1.0183) for AUC0-t, 0.9191 (90%CI 0.8279-1.0203) for AUC0-∞ and 0.9135 (90%CI 0.8324-1.0026) for Cmax. Plasma concentration-time profiles were similar. One AE of fever was reported after administration of T; no serious adverse event was reported.
CONCLUSIONS: Gabantin® GRS 600 Tablet ER OD of Sun Pharma had a similar pharmacokinetic profile and was bioequivalent to Gralise® in healthy subjects under fed conditions with good safety and tolerability profiles.
PMID:42387089 | DOI:10.1007/s40268-026-00547-8
