The pharmacokinetic profiles of trientine dihydrochloride were similar after fast and slow dissolution capsule administration, indicating no significant difference in absorption.
Does the dissolution profile (fast vs. slow) of trientine dihydrochloride affect its pharmacokinetics and copper parameters in healthy subjects?
Fast and slow dissolution profiles of trientine dihydrochloride capsules result in similar pharmacokinetic profiles.
Absolute Event Rate: 0% vs 0%
PURPOSE: Trientine dihydrochloride (TETA-2HCl) is an established treatment for Wilson disease. We assessed different dissolution profiles of TETA-2HCl capsules on the pharmacokinetics (PK) of trientine (TETA) and on direct copper (Cu) parameters. METHODS: In this open-label, randomized, two way cross-over study, 24 healthy subjects received two single oral doses of 600 mg TETA-2HCl with a washout of at least one week; one dose with a fast and one dose with a slow dissolution profile. Blood and urine samples were collected up to 48 h for analysis of plasma TETA and its metabolites, N1-acetyltriethylenetetramine (MAT) and N1-N10-diacetyltriethylenetetramine (DAT), serum Cu, ceruloplasmin (Cp) and urinary Cu excretion (UCE). The effect of dissolution profile on the PK was assessed through the ratio of geometric mean ratios (GMRs) and two-sided 90%-confidence intervals (CI) of the fast vs. slow dissolution profile. RESULTS: The C CONCLUSION: The pharmacokinetic profiles of TETA after administration of TETA-2HCl capsules with fast and slow dissolution characteristics were similar. Though the lower 90%-CI for AUC
Weiss et al. (Mon,) reported a other. The pharmacokinetic profiles of trientine dihydrochloride were similar after fast and slow dissolution capsule administration, indicating no significant difference in absorption.