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Solifenacin demonstrates high absolute bioavailability in healthy men
Mirjam E Kuipers1, Walter J J Krauwinkel, Hans Mulder
1Yamanouchi Europe BV, Leiderdorp, The Netherlands. kuipers.nl@yamanouchi-eu.com
Drugs in R&D
|August 6, 2004
Summary
Solifenacin succinate, a new overactive bladder treatment, shows high oral bioavailability (88%) in a pharmacokinetic study. This suggests it may be more consistently absorbed than other antimuscarinic drugs.
Area of Science:
- Pharmacology
- Clinical Pharmacology
- Urology
Background:
- Solifenacin succinate is a novel muscarinic receptor antagonist for overactive bladder.
- Its pharmacokinetic profile, particularly oral bioavailability, requires thorough investigation.
Purpose of the Study:
- To determine the absolute bioavailability of a single 10 mg oral dose of solifenacin.
- To assess the pharmacokinetics of solifenacin in healthy male volunteers.
Main Methods:
- A single-center, randomized, crossover study involving 12 healthy men.
- Administration of solifenacin 10 mg orally and 5 mg intravenously with a 14-day washout period.
- Pharmacokinetic analysis performed on nine completers.
Main Results:
- Absolute oral bioavailability of solifenacin was high at 88.0% (95% CI: 75.8, 102.1).
- The drug exhibited low clearance (9.39 L/h) and a large volume of distribution (599 L).
- Solifenacin was generally well-tolerated, with headache and somnolence as common adverse events.
Conclusions:
- Solifenacin demonstrates high absolute oral availability (88%), indicating good absorption.
- This high bioavailability may offer advantages over other antimuscarinic agents in terms of consistency and variability.