Physiological study
Conditions
Interventions
Group 1: Single dose of a stable isotope-labelled dipeptide mixture in dose cohorts of n = 3. Each dose cohort receives one defined dose once. Observation afterwards is for 24h. 4 dose cohorts are pla
Sponsors
Institut für Pharmakologie, Universitätsmedizin Greifswald
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: - understands the study purpose and design - contractually capable and provides signed informed consent form - healthy condition or mild and/or well treated forms of allergies, asthma, hypertension, and orthopedic diseases - a maximum of 2 chronically taken drugs
Exclusion criteria
Exclusion criteria: a. BMI > 35 kg/m2 and 2x ULN) g. reduced renal function (eGFRMDRD < 60 ml/min/1,7m2) h. known history of coeliac disease or gluten intolerance i. psychiatric disease or drug dependency j. use of recreational drugs more than twice a week k. poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mass spectrometry signal for each administered labelled dipeptide in blood and urine samples. If the signal allows quantification of the dipeptides and calculation of pharmacokinetic parameters, the study is successful. | — |
Secondary
| Measure | Time frame |
|---|---|
| - AUC0-10h for each labelled dipeptide - AUC0-72h for each labelled dipeptide - Tmax of each labelled dipeptide - Cmax of each labelled dipeptide - renal clearance of each labelled dipeptide | — |
Countries
Germany
Contacts
Public ContactStefan Engeli
Institut für Pharmakologie, Universitätsmedizin Greifswald
Outcome results
None listed