Hepatic Function.
Conditions
Interventions
Trade Name: FRENADOL COMPLEX
Product Name: FRENADOL COMPLEX
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Other descriptive name: PARACETAMOL
Conc
Sponsors
INSTITUTO DE INVESTIGACION SANITARIA LA FE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group volunteers: volunteer subjects without severe liver pathology associated. Group patients: Patients who are to undergo abdominal surgery (liver resection preferably in the context of the underlying pathology, eg liver metastases, hepatic adenoma, cholangiocarcinoma, etc ...). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Group volunteers: under 18 years, pregnant and lactating women, allergy to any of the active substances or excipients, allergy to acetylsalicylic acid, liver pathology associated (cirrhosis, hepatitis, liver tumor pathology), moderate consumption of alcohol, renal failure (creatinine of 1.2mg/dl or less glomerular filtration of 90 ml / min). Group patients: below 18, allergy to any of the active ingredients or allergy to acetylsalicylic acid, renal failure (creatinine of 1.2mg/dl or less glomerular filtration of 90 ml / min), the appearance of other pathological conditions over study that contraindicate surgery. Pregnant women and lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the minimum dose and pharmacokinetics (Tmax, Cmax, metabolite ratios / active ingredient in blood and urine) for each of the active ingredients of Frenadol COMPLEX ® (acetaminophen, dextromethorphan, chlorpheniramine and caffeine) in volunteer subjects. and the optimum time for taking samples (blood and urine) for the efficient determination of the metabolites Administer the drug that is the basis of Hepatotest (Frenadol Complex) to patients who are operated on for liver surgery preoperatively, determining the presence of metabolites in blood and urine. After the taking of a tissue sample is determined activity per gram of tissue of the enzymes that are involved in the metabolism of the aforementioned drugs;Secondary Objective: Establish a procedure for sampling, processing and analysis that is robust, reproducible and consistent with current clinical practice for drug administration and measurement of metabolites in blood and urine. Development of an algorithm for correlating the results of metabolite concentrations in serum / urine with the enzymatic activities measured in liver tissue;Primary end point(s): Tmax, Cmax, metabolite ratios / active substance in blood and urine They determine the activity per gram of tissue enzymes involved in drug metabolism in liver biopsy;Timepoint(s) of evaluation of this end point: At the end. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation of active ingredients and metabolites in blood and urine, and liver enzyme activity in liver biopsy;Timepoint(s) of evaluation of this end point: At the end. | — |
Countries
Spain
Contacts
Public ContactUREC
IIS LA FE
Outcome results
None listed