Overview
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Radboud UniversityCollaborator:
Dutch Diabetes Research Foundation
Criteria
Inclusion Criteria:- at least 18 and no older than 65 on the day of first dosing
- healthy
- Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
- In general, results of haematology and chemistry should be within the laboratory's
reference ranges. Determinants of renal and hepatic function should be within twice
the upper limit of normal range.
Exclusion Criteria:
- Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
- history of smoking within the past year
- history of or current abuse of drugs, alcohol and/or solvents
- Current use of any (over the counter) medication potentially influencing heme
oxygenase or the cardiovascular system
- Inability to understand the nature and extent of the trial and the procedures required
- Participation to a drug trial within 60 days prior to the first dose
- Febrile illness within 3 days before the first dose
- Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in
the HO-1 promoter region