Pharmacokinetics of Sumatriptan 25-mg Oral Tablet Versus 25-mg Extemporaneous Suppository in Healthy Volunteers
Author(s): Desai Hiral D, Shirley Kara L, Penzak Scott R, Strom J Grady, Hon Yeun Yi, Spratlin Vicky, Jann Michael W
Issue: Nov/Dec 2003 - Compounding for Investigational Studies
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Page(s): 481-484
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Abstract: The pharmacokinetics of an extemporaneous 25-mg suppository
formulation of sumatriptan were compared to
those of the marketed 25-mg oral tablet. Sixteen healthy
volunteers enrolled in this open-label, two-way crossover
study. Fifteen subjects completed the study. The pharmacokinetics
of the suppository and the oral tablet were significantly
different. Tmax was observed at 0.5 hours in 12 of
15 subjects with the extemporaneous suppository, compared
with the range of 0.75 hours to 1.5 hours in 13 of 15
subjects with the oral tablet. The mean Cmax and area under
the plasma concentration time curve were 5.4-fold and
fourfold greater for the suppository than for the oral
tablet. Both formulations were well tolerated, with mild
headache experienced in only three subjects. Based upon
its pharmacokinetic profile, the extemporaneous suppository
may represent a useful alternative therapeutic administration
route for some patients.
Related Keywords:
Sumatriptan, pharmacokinetics of
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