Key result
Single oral doses of dolasetron mesylate up to were well tolerated in healthy male volunteers, with transient, mild-to-moderate adverse events and asymptomatic, dose-dependent ECG changes.
Why the study?
Is single-dose oral dolasetron mesylate safe and well-tolerated compared to placebo in healthy male volunteers?
RCT (n=120)
Double-blind
No
Is single-dose oral dolasetron mesylate safe and well-tolerated compared to placebo in healthy male volunteers?
Single oral doses of dolasetron mesylate up to 400 mg are well tolerated in healthy male volunteers, despite asymptomatic, dose-dependent ECG interval prolongations.
Answers are grounded in this paper and cite their sources.
Supports advancing oral dolasetron to patient trials with ECG monitoring; extends IV safety data to single oral doses.
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Dixon et al. (1996) conducted an RCT in Healthy volunteers (n=120). Oral dolasetron mesylate vs. Placebo was evaluated on Safety, tolerability, and pharmacokinetics. Single oral doses of dolasetron mesylate up to were well tolerated in healthy male volunteers, with transient, mild-to-moderate adverse events and asymptomatic, dose-dependent ECG changes.
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