Absorption of X-Pro-Dipeptides following Oral Ingestio
- Conditions
- Physiological study
- Registration Number
- DRKS00033099
- Lead Sponsor
- Institut für Pharmakologie, Universitätsmedizin Greifswald
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
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
a.BMI > 35 kg/m2 and <18 kg/m2
b.known pregnancy or lactation period
c.women: positive urine pregnancy test at screening or pharmacokinetic
visit
d.anemia (hemoglobin < 13 g/dl (8,07 mmol/l) in men or < 12 g/dl (7,45
mmol/l) in women
e.blood donation within the last 4 weeks
f.elevated liver function tests (ALAT, ASAT, yGT, Bilirubin > 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - AUC0-10h for each labelled dipeptide<br>- AUC0-72h for each labelled dipeptide<br>- Tmax of each labelled dipeptide<br>- Cmax of each labelled dipeptide<br>- renal clearance of each labelled dipeptide