ArticleDrugs in R&D2026
Comparative Pharmacokinetics of Trientine Dihydrochloride Capsules: A Randomized, Open-Label, Reference-Controlled, Two-Period Crossover Study in Healthy Volunteers.
Article in Drugs in R&D, 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
objectivesTrientine dihydrochloride (TETA-2HCl) is an oral copper chelator used for Wilson disease. Because available formulations differ in marketed strength and may have formulation-specific pharmacokinetic properties, this study compared a 250 mg test capsule and a 300 mg reference capsule administered under fasting conditions.
methodsThis randomized, open-label, balanced, two-treatment, two-period, two-sequence crossover study enrolled 36 healthy adults. Plasma samples collected over 48 h after single-dose administration were analyzed for parent trientine and N1-acetyltriethylenetetramine using validated liquid chromatography (LC)-tandem mass spectrometry (MS/MS). The primary comparative pharmacokinetic evaluation was based on parent trientine C
resultsThirty-five participants were included in the pharmacokinetic and statistical analyses. Parent trientine was absorbed more rapidly after the test formulation, with median T
conclusionsAt the administered strengths, AUC
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