A study of the effects of zimelidine on the pharmacokinetics and pharmacodynamics of temazepam in healthy volunteers.

In this double-blind two-period crossover study, ten healthy volunteers received either 200 mg zimelidine each morning for 5 days, or placebo on the same schedule. On day 5 they received 20 mg temazepam 2 h after zimelidine or placebo. A battery of psychometric tests and subjective measurements was carried out on days 4 and 5. Blood samples were collected on day 5 for pharmacokinetic analysis of temazepam. All the measures of psychomotor performance showed the effects of temazepam, as did two of the subjective measures, the "alert/drowsy" and "steady/dizzy" visual analogue scales. No effect of zimelidine alone on performance or subjective state was seen. Zimelidine showed no discernible interaction with the effects of temazepam as assessed by subjective reports, by psychomotor tests, or by pharmacokinetic analysis.

RCT Entities:   Population Interventions Outcomes