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Bioavailability and Dose Proportionality of Intramuscular Diazepam Administered by Autoinjector
Author(s) -
Lehmann Craig,
Wannarka Gerald L.
Publication year - 2008
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270007311572
Subject(s) - bioequivalence , diazepam , medicine , pharmacokinetics , crossover study , bioavailability , anesthesia , pharmacology , alternative medicine , pathology , placebo
A diazepam 10‐mg autoinjector was evaluated in bioequivalence and dose proportionality studies; both involved 24 young, healthy subjects and used randomized, open‐label, 2‐treatment, 2‐period crossover designs with a 3‐week washout period between treatments. The bioequivalence study compared a single diazepam 10‐mg autoinjector with a conventional needle and syringe containing 10 mg of diazepam injectable. The dose proportionality study compared the pharmacokinetics of a single diazepam 10‐mg autoinjector with that of 2 diazepam 10‐mg autoinjectors given simultaneously (20 mg). Injections were intramuscular in the midanterolateral thigh in both studies. The studies showed that the diazepam autoinjector produced consistent plasma diazepam levels, with a rapid onset of absorption. The diazepam 10‐mg autoinjector given intramuscularly was bioequivalent to a conventional syringe containing diazepam 10 mg. A single (10‐mg) autoinjector and 2 (20‐mg) diazepam autoinjectors administered simultaneously produced plasma diazepam concentrations that were essentially dose proportional.