Trial reportBritish journal of clinical pharmacology2026
A phase 1 evaluation of inhaled oxytocin: Physiologically-based pharmacokinetic model informed dosing of a novel heat-stable oxytocin delivery system.
Trial report in British journal of clinical pharmacology, 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
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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
1 citing paper in PubMed.
- A phase 1 evaluation of inhaled oxytocin: Physiologically-based pharmacokinetic model informed dosing of a novel heat-stable oxytocin delivery system.British journal of clinical pharmacology · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
aimTo develop and validate a physiologically-based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non-pregnant female participants.
methodA general PBPK model for inhaled oxytocin in non-pregnant female participants was developed with the ability to estimate clinical exposure for new devices and deposition characteristics. This was used to select the oxytocin dose range for a randomized, single-centre, partially single-blind, placebo-controlled, fixed-sequence phase 1 study in comparison to standard of care injectable doses in a part cross-over design. Participants received increasing inhaled oxytocin doses (150 μg, 300 μg, 600 μg and 900 μg) in single and/or repeat dose regimens. The primary endpoints were pharmacokinetic characteristics and local tolerability following inhaled dosing.
resultsFifteen of 20 randomized participants completed the study. The pharmacokinetics following inhaled oxytocin administration were consistent with intramuscular dosing with the 150 μg (C
conclusionFurther development of inhaled oxytocin as an innovative product to address preventable postpartum haemorrhage in low-resource settings is warranted.
trial registrationAustralia New Zealand Clinical Trial Registry (ACTRN12622001077752p) registered 04/08/2022.
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