Oral pharmacokinetics of pirenzepine in man following single and multiple doses
International Journal of Pharmaceutics(1986)
Abstract
The relative bioavailability of pirenzepine tablets (50 mg and two 25 mg) was assessed in 18 subjects in a single dose crossover study. The relative bioavailability of the tablet formulations, compared to a 50 mg oral reference solution given in the fasted state, was unity. The parameters of area under the curve, peak pirenzepine plasma concentration and time-to-peak demonstrated no significant difference for tablet formulations as compared to a 50 mg oral reference solution. After single oral dosing, the harmonic mean half-life of pirenzepine was 10.2 h. The mean renal clearance of 110 ± 12 ml/min approximated glomerular filtration rate. Twelve of the 18 subjects were administered the 50 mg tablet every 8 h for 6 days to assess the multiple dose pharmacokinetics of oral pirenzepine. Drug accumulation to steady state occurred within 4 half-lives as predicted from single dose data. The harmonic mean half-life of pirenzepine after multiple oral dosing was 12.4 h.
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Key words
pirenzepine,Gastrozepin,human pharmacokinetics,single dose,multiple dose,relative bioavailability
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