Pharmacokinetics of an osmotically controlled delivery indomethacin preparation in normal volunteers.

Abstract

Indomethacin is still used commonly for the treatment of rheumatic diseases but is associated with side effects, particularly headache, in a number of patients. A controlled or sustained release formulation of indomethacin might provide lower peak plasma levels and thus reduce side effects while still maintaining adequate plasma levels to control pain and inflammation. In this single dose crossover study, normal volunteers received the new formulation of indomethacin (Indocid GITS 6/85) fasting or with a standard meal, indomethacin 75 mg with a standard meal or indomethacin 25 mg three times daily with a standard meal. Plasma concentration data showed that peak plasma levels were reduced but..