Clinical Trials Detalhe
Variability of Sulfotransferase 1A1 Activity in Humans: an Approach to Improve Predictive Drug Response - Part I: Analysis of Intraindividual Variation in Healthy Adults
General Information
Gender
ALL
Age
N/A
Phase
PHASE1
Study Type
INTERVENTIONAL
Location
Hospital da Luz (Lisbon, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT03182595Summary
An open-label, single centre, nonrandomized clinical study in healthy volunteers, with intervention over a 13---week period. After written informed consent, subjects will undergo screening evaluations (Visit 1). One week after visit 1, subjects who meet the selection criteria will enter a run---in period of 8 weeks where participants will receive paracetamol 1g tablet and collect a blood sample at monthly intervals (visits 2, 3 and 4). A final visit for safety assessment will take place at week 13 (visit 5). Blood samples will be used to quantify P, PG e PS.
Conditions
Healthy Volunteers
Eligibility
Inclusion Criteria: * Healthy males and females, over 18 years of age, * Informed of the nature of the study and giving written informed consent, * Report no significant diseases during screening, * Have normal CBC, renal function and liver enzymology, * Have no contraindication for paracetamol, * Be on no regular medical treatment, except for contraceptives, * Be able to communicate effectively with study personnel. Exclusion Criteria: * Hypersensitivity or idiosyncratic reaction to paracetamol, * Intake of any medication, except for contraceptives, within 14 days before start of the study, * Pregnancy or breastfeeding, * BMI \<18 kg/m2, * Participation in a clinical study of any investigational product 1 month prior to visit 1 or during the study.