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Bioavailability of indomethacin tablets in men volunteers
Abstract:
Indomethacin bioavailability was compared in 22 healthy men who received two tablet dosage formulations and a capsule formulation of indomethacin in a three-way crossover study. In each study period, 50 mg of the indomethacin formulation (25-mg or 50-mg tablets or 50-mg capsules) was administered as a single dose to fasting subjects. Thirteen blood samples were collected at intervals over 24 hours after each dose. Urine samples were collected for 12 hours before each dose and 48 hours after each dose. Serum indomethacin concentrations were measured by a gas chromatographic procedure. The extent of indomethacin absorption for the two tablet formulations was not significantly different from that for the reference capsule. A trend toward earlier and higher peak serum concentrations with the capsule was observed. There was less than 20% difference in mean values for area under the concentration-time curve (AUC) for the three formulations. More than 75% of the subjects had serum concentrations falling between 75 and 125% of the mean serum concentrations. The extent of absorption of indomethacin from the two tablet formulations was similar to that from the capsule.