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This research aimed to evaluate the safety, tolerability, and pharmacokinetics of high doses of ivermectin in healthy adults.

Safety, Tolerability, and Pharmacokinetics of Escalating High Doses of Ivermectin in Healthy Adult Subjects

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This research aimed to evaluate the safety, tolerability, and pharmacokinetics of high doses of ivermectin in healthy adults.
Double-blind, placebo-controlled dose escalation study, n=68 subjects.
Subjects received 30, 60, 90, or 120 mg of ivermectin in various regimens, including doses with food.
Safety was assessed through evaluations of known CNS effects and toxicity.
No significant CNS toxicity was observed for doses up to 10 times the FDA-approved maximum.
All doses produced a mydriatic effect comparable to placebo.
Pharmacokinetic analysis showed dose proportionality with a t(max) of approximately 4 hours and t1/2 of around 18 hours.

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Randomized trial evaluated safety and pharmacokinetics of ivermectin at high doses in healthy adults, suggesting good tolerability.

Guzzo et al. (2002) studied this question.

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