2022
DOI: 10.1002/cpdd.1107
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Intravenous Perampanel as an Interchangeable Alternative to Oral Perampanel: A Randomized, Crossover, Phase I Pharmacokinetic and Safety Study

Abstract: Intravenous (IV) drug administration enables treatment of epilepsy when oral administration is temporarily not feasible. Perampanel is a once‐daily antiseizure medication currently available as oral formulations. Study 050 (NCT03376997) was an open‐label, randomized, single‐dose, crossover study to evaluate the interchangeability of oral and IV perampanel in healthy subjects (N = 48). Bioequivalence of single 12‐mg doses of IV (30‐, 60‐, or 90‐minute infusion) and oral perampanel, ≥6 weeks apart, was assessed.… Show more

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Cited by 4 publications
(8 citation statements)
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“…The demographics of healthy subjects were generally similar across IV infusion arms. Overall, 52.1% of the healthy subjects were male, with a mean (standard deviation [SD]) age of 39.0 (9.4) years 17 . Demographics and baseline clinical characteristics of healthy subjects stratified by race, are shown in Table S1.…”
Section: Resultsmentioning
confidence: 99%
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“…The demographics of healthy subjects were generally similar across IV infusion arms. Overall, 52.1% of the healthy subjects were male, with a mean (standard deviation [SD]) age of 39.0 (9.4) years 17 . Demographics and baseline clinical characteristics of healthy subjects stratified by race, are shown in Table S1.…”
Section: Resultsmentioning
confidence: 99%
“…Healthy adult subjects aged 20‐55 years with a body mass index of 18‐32 kg/m 2 were eligible to participate in this study. Briefly, key exclusion criteria included pregnancy, clinically significant illness requiring medical treatment within 8 weeks of dosing, clinically significant infection or disease that may influence the outcome of the study within 4 weeks of dosing, a history of gastrointestinal surgery that may affect PK profiles of perampanel, and any clinically abnormal symptom found at screening via medical history and physical examination 17 …”
Section: Methodsmentioning
confidence: 99%
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