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Related Experiment Videos

Zaleplon pharmacokinetics and absolute bioavailability.

A S Rosen1, P Fournié, M Darwish

  • 1Wyeth-Ayerst Research, Radnor, PA 19087, USA.

Biopharmaceutics & Drug Disposition
|April 22, 1999
PubMed
Summary
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This study evaluated zaleplon

Area of Science:

  • Pharmacology and Therapeutics
  • Clinical Pharmacokinetics

Background:

  • Zaleplon is a novel nonbenzodiazepine hypnotic agent.
  • Understanding its pharmacokinetic profile is crucial for clinical use.
  • Presystemic metabolism significantly impacts oral drug bioavailability.

Purpose of the Study:

  • To determine the pharmacokinetics of zaleplon.
  • To assess the absolute oral bioavailability of zaleplon.
  • To evaluate the extent of presystemic metabolism of zaleplon.

Main Methods:

  • A partially randomized, single-dose, four-period crossover study.
  • 23 healthy subjects participated.
  • Administered intravenous (i.v.) and oral doses of zaleplon (1, 2.5, and 5 mg).

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Main Results:

  • Zaleplon exhibited moderate to high systemic clearance (0.94 L/h/kg).
  • Rapid elimination with a half-life (t1/2) of approximately 1.05 hours.
  • Absolute oral bioavailability was determined to be 30.6%.

Conclusions:

  • Zaleplon undergoes significant presystemic metabolism.
  • The drug is rapidly absorbed orally, with elimination kinetics similar to i.v. administration.
  • The findings provide essential data for zaleplon's therapeutic application.