Trial reportEuropean journal of drug metabolism and pharmacokinetics2026
Population Pharmacokinetics of Intranasal Amiloride in Healthy Volunteers.
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. Not yet cited in PubMed.
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Authors and funding
7 authors.
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Abstract
BACKGROUND AND
objectiveAmiloride, an acid-sensing ion channel (ASIC) blocking agent with demonstrated anti-panic effects in preclinical models, is a promising candidate for rapid treatment of panic attacks. Intranasal administration enables rapid systemic uptake, and single-dose pharmacokinetics (PK) of intranasal amiloride in healthy adults have been described, but its population PK (PopPK) properties, including variability and absorption pathways, remain undefined. This study aimed to develop a PopPK model in healthy adults to characterize intranasal amiloride absorption kinetics and systemic exposure.
methodsHealthy volunteers (n = 15) randomized equally to three dose groups (n = 5 per group) received 0.2, 0.4, or 0.6 mg intranasal amiloride via a mucosal atomization device, and plasma samples were collected over 24 h. PopPK modelling was performed in NONMEM
resultsA first-order parallel dual absorption model with rapid nasal uptake and a slower secondary route via a transit compartment, combined with two-compartment disposition, best described the data. Key parameter estimates included a slow absorption rate constant of 0.136 h
conclusionsIntranasal amiloride pharmacokinetics are best described by a dual-pathway absorption model with rapid and delayed uptake. This PopPK model provides a quantitative foundation for dose selection and further clinical development as a rapid-acting treatment for panic attacks.
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Registered trials
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