A randomised, open-label study evaluating the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL by comparing it against the current marketed Cuprior® formulation (450mg trientine base, twice daily) in healthy male and female participants.
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Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
Timeframe: Up to 48 hours post first dose initiation.
Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Timeframe: Up to 48 hours post first dose initiation.
Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (AUC) of TETA in Plasma
Timeframe: Up to 48 hours post first dose initiation.
Plasma Concentrations (Cmax) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Time) of TETA in Plasma
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Concentration) of TETA in Plasma
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (AUC) of MAT in Plasma
Timeframe: Up to 48 hours post first dose initiation
Plasma Concentrations (Cmax) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Time) of MAT in Plasma
Timeframe: Up to 48 hours post first dose initiation
Pharmacokinetic Parameters (Concentration) of MAT in Plasma
Timeframe: Up to 48 hours post first dose initiation
Pharmacokinetic Parameters (AUC) of DAT in Plasma
Timeframe: Up to 48 hours post first dose initiation.
Plasma Concentrations (Cmax) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Time) of DAT in Plasma
Timeframe: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Concentration) of DAT in Plasma
Timeframe: Up to 48 hours post first dose initiation.