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Pharmacokinetics of Clozapine and Norclozapine and the Effect of Pantoprazole

NCT07262736 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers - Male and Female

Interventions

DRUG

clozapine

Single dose of 12.5 mg clozapine (half 25 mg tablet)

DRUG

pantoprazole

Five daily doses of pantoprazole tablets 40 mg to be started four days prior to the clozapine administration

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-06
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262736 on ClinicalTrials.gov