At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole
In Brief
A Phase 1 clinical trial evaluating clozapine and pantoprazole for Healthy Volunteers - Male and Female. Completed, enrolled 33 participants across 1 site.
Detailed Summary
Clozapine is an effective treatment for patients with schizophrenia who do not respond to other therapies, but its blood concentration varies widely between individuals due to genetic and physiological differences. Proton pump inhibitors such as pantoprazole are often prescribed in this population to prevent stomach discomfort, yet their impact on clozapine exposure has not been fully characterized. This clinical study will investigate the pharmacokinetics of clozapine and its main metabolite norclozapine, the influence of individual characteristics on drug exposure, and the effect of pantoprazole coadministration. Healthy adult volunteers will participate in a randomized open label cross over design, receiving a single dose of clozapine alone and again after pantoprazole treatment. Outcomes include clozapine and norclozapine plasma concentration time profiles, pharmacokinetic parameters, and safety assessments.
Study Details
Timeline
Interventions
Single dose of 12.5 mg clozapine (half 25 mg tablet)
Five daily doses of pantoprazole tablets 40 mg to be started four days prior to the clozapine administration