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Gastro-intestinal blood loss with high dose tilcotil (Ro 12-0068) and aspirin: an open crossover clinical trial and pharmacokinetic assessment in normal volunteers

1983; Taylor & Francis; Volume: 8; Issue: 6 Linguagem: Inglês

10.1185/03007998309111747

1473-4877

H. A. Bird, M. E. Pickup, P. W. J. Taylor, J. R. Lowe, M. McEvoy, D. B. Galloway, V Wright,

Pharmaceutical Practices and Patient Outcomes

An open crossover study was carried out in 8 normal volunteer subjects to compare faecal blood loss resulting from tilcotil (Ro12-0068), a new anti-inflammatory agent, and from enteric-coated aspirin. After a 1-week run-in period, subjects were allocated at random to receive treatment for 2 weeks with either 40 mg tilcotil as a single dose per day or aspirin, 900 mg 4-times daily, reduced if necessary to a maximum tolerated dose. Subjects were then crossed over to the alternative treatment for a further 2 weeks. The results showed that tilcotil produced less blood loss, assessed by a radioactive labelling method, and was better tolerated than aspirin. Plasma concentrations of tilcotil showed that the drug's half-life was approximately 50 hours, compatible with once daily dosage, and steady state concentrations on multiple dosing were reached after 10 to 12 days.