I10 I50
Conditions
Interventions
Group 1: Healthy adults receive a single dose of 20 mg enalapril maleate (EnaHEXAL) orally as a tablet
Sponsors
Institut für Klinische Pharmazie und Pharmakotherapie der Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: - No intake of other drugs - Body weight of more than 50 kg
Exclusion criteria
Exclusion criteria: - Consent to participate in the study will not be granted or will be withdrawn - Laboratory parameters (especially electrolytes) are outside the normal range - Allergies to the drug to be tested are known - Structural heart disease is present - Structural kidney disease is present - Other severe organ disease is present - Other diseases are present that require pharmacotherapy - Angioedema has occurred in your subject's medical history - There is a known tendency to urticaria - Desensitisation therapy for insect venoms has been carried out within the last 4 weeks - There are medical reasons against the collection of blood samples - Pregnancy - History of low blood pressure values (<90/60 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to demonstrate the usefulness of low-volume assays for determining enalapril and enalaprilate concentrations and pharmacodynamic parameters (renin, plasma renin activity, angiotensin I and angiotensin II) in a proof-of-concept study in healthy adults. | — |
Countries
Germany
Contacts
Public ContactStephanie Läer
Institut für Klinische Pharmazie und Pharmakotherapie der Heinrich-Heine-Universität Düsseldorf
Outcome results
None listed