Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
- Registration Number
- NCT03333603
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia
- Detailed Description
Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description esomeprazole esomeprazole esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
- Primary Outcome Measures
Name Time Method Plasma Concentration analysis It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose The pharmacokinetic parameters for esomeprazole and its main metabolites
- Secondary Outcome Measures
Name Time Method CYP2C19 genotypes analysis The genotype will be assessed on Day 1 Investigators will genotype CYP2C19 genotype to determine that which metabolized type (poor metabolizer, intermediate metabolizer, and good metabolizer) of patients belong to.
Trial Locations
- Locations (2)
National Taiwan University Hospital Yunlin Branch
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan