The normal physiological responses in healthy subjects MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Allopurinol
Pharmaceutical Form: Tablet
INN or Proposed INN: ALLOPURINOL
CAS Number: 315-30-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharm
Sponsors
Department of Medical Research, Regional Hospital Holstebro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-40 years, BMI 18,5-30, women must use contraception 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Tobacco smoking, medicin or substance abuse, Weekly consumption of more than 21 standard drinks of alcohol for men and 14 standard drinks of alcohol for women (1 danish standard drink equals 12 grams of alcohol), medical treatment in the last 2 weeks except for contraception, pregnancy or nursing, diabetes mellitus, eGFR 140/90 mmHg, donation of blood within 1 month of the first day of investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate how inhibition of xanthine oxidase, angiotensine converting enzyme and carbonic anhydrase affects the response to sodium nitrite infusion in healthy subjects;Secondary Objective: Not applicable;Primary end point(s): Fractional sodium excretion (FENa);Timepoint(s) of evaluation of this end point: Subjects will be followed with repeated blood samples for the duration of the examination day, from 8 AM to 2 PM. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Subjects will be followed with repeated measurements, blood and urine samples for the duration of the examination day, from 8 AM to 2 PM.;Secondary end point(s): Brachial blood pressure and central aortic systolic blood pressure Glomerular filtration rate Absolute sodium excretion and proximal tubular sodium transport (lithium clearance) Plasma levels of renin, angiotensin 2, aldosteron, atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), cGMP, endothelin and vasopressin Urinary excretion of aquaporin 2, ENaC, c-AMP, NKCC2 Renal clearance of nitrate and nitrite Free water clearance | — |
Countries
Denmark
Contacts
Public ContactJeppe Bakkestrøm Rosenbæk
Department of Medical Research, Regional Hospital Holstebro
Outcome results
None listed