Variability of Sulfotransferase Activity in Humans: an Approach to Improve Predictive Drug Response Part II: Analysis of Interindividual Variation in Hypertensive Patients
NCT06782204 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2025-01-17
Summary
An open-label, single center, nonrandomized clinical study in hypertensive patients, with intervention, over a 5-week period. After written informed consent, subjects will undergo screening evaluations, including blood and urine sampling (Visit 1). After visit 1, subjects who meet the selection criteria will enter a run-in period where they will receive paracetamol 1g tablet and collect blood and urine samples 2 hours afterwards (visit 2). A final visit for safety assessment will take place at week 5 (visit 3).
Blood and urine samples will be used to quantify paracetamol and its metabolites.
Conditions
Interventions
- DRUG
-
At visit 2, complying subjects will receive a tablet containing 1 gram of paracetamol and have blood and urine samples collected 2 hours after administration.
Sponsors & Collaborators
-
Universidade Nova de Lisboa
collaborator OTHER -
Hospital da Luz, Portugal
lead OTHER
Principal Investigators
-
Natália Marto, MD · Hospital da Luz
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-01
- Primary Completion
- 2021-01-01
- Completion
- 2021-04-01
Countries
- Portugal
Study Locations
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