Healthy Volunteers - Male and Female
Conditions
Brief 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.
Interventions
DRUGclozapine
Single dose of 12.5 mg clozapine (half 25 mg tablet)
DRUGpantoprazole
Five daily doses of pantoprazole tablets 40 mg to be started four days prior to the clozapine administration
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult volunteers aged 18 to 50 years 2. No history of chronic medical or psychiatric disease, as confirmed by baseline medical evaluation, medical history, and electrocardiogram (ECG) 3. No use of any medications for at least two weeks before study initiation
Exclusion criteria
1. Pregnant or breastfeeding women 2. Current smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | From pre-dose to 8 hours after a single oral dose of clozapine | Maximum plasma concentration of clozapine following a single oral dose |
| Area Under the Plasma Concentration-Time Curve (AUC) | From pre-dose to 8 hours after dosing | AUC of clozapine plasma concentration from time zero to the last measurable concentration following a single oral dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) | From pre-dose to last measurable concentration | Area under the plasma concentration-time curve from time zero extrapolated to infinity |
| Time to Peak Concentration (Tmax) | From pre-dose to 8 hours after dosing | Time to reach maximum observed plasma concentration of clozapine |
Countries
Malaysia
Outcome results
None listed