Circulatory System
Conditions
Interventions
Enalapril 10 mg tablets Dawapril Brand by Dawa Life sciences
Enalapril 10mg tablets EnaDenk brand by Denk Pharma
Sponsors
KENYA MEDICAL RESEARCH INSTITUTE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Biological male sex 2. Age between 18 to 55 years (both inclusive) 3. Has a BMI of 20 to 30 kg/m2 (both inclusive) 4. Willing and able to provide informed consent
Exclusion criteria
Exclusion criteria: 1. History of drug abuse or alcohol abuse. 2. Current medical treatment or treatment in the last one week. 3. Current acute or chronic illness 4. Laboratory findings suggestive of liver disease, kidney disease, blood disorder or systemic infection 5. Currently enrolled in another interventional trial with an investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (C???) of enalapril and enalaprilat, and area under the concentration-time curve from time zero to the last measurable concentration (AUC0??) and extrapolated to infinity (AUC0?8) for enalapril and enalaprilat following oral administration of enalapril 10mg tablet. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum concentration (T???) of enalapril and enalaprilat, and safety and tolerability assessed through adverse event monitoring. | — |
Countries
Kenya
Contacts
Public ContactIsaac Githaiga
DIRECTOR
Outcome results
None listed