October 1, 1992Clinical Pharmacology & Therapeutics
Prediction of sotalol-induced maximum steady-state QTc prolongation from single-dose administration in healthy volunteers
Why the study?
Does a single 320 mg test dose of sotalol predict maximum steady-state QTc prolongation in healthy volunteers?
Population
10 healthy volunteers
Comparison
Racemic sotalol oral administration vs Crossover design comparing different doses and…
Design
RCT, randomized crossover protocol
Authors
Discussion
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Member takes
Implication
Single 320 mg sotalol dose predicts steady-state QTc prolongation; supports test-dose strategy to guide safer initiation in practice.
Structured PICO
Does a single 320 mg test dose of sotalol predict maximum steady-state QTc prolongation in healthy volunteers?
P
Population
10 healthy volunteers
I
Intervention
Racemic sotalol oral administration (single-dose and repeated administration of three doses, including a 320 mg test dose)
C
Comparator
Crossover design comparing different doses and single versus repeated administration
O
Outcome
QTc interval prolongation and its relationship with sotalol plasma concentrationssurrogate
A single 320 mg test dose of sotalol can accurately predict the expected maximal increase in steady-state QTc duration in healthy subjects.
Cite This Study
Coz et al. (1992) studied this question.