bioequivalence study in healthy subjects
Conditions
Interventions
Group 1: Sequence A: Fixed dose combination / two single doses
Group 2: Sequence B: Two single doses / fixed dose combination
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Properly executed written informed consent form (ICF). - Healthy males and females, aged 18 to 60 years, inclusive, at the screening visit. - BMI between 18.5 Kg/m2 and 30 Kg/m2, inclusive, and weighs at least 50 kg at screening. - Extensive metabolizers for CYP2D6. - Systolic blood pressure (SBP) = 90 mmHg and diastolic blood pressure (DBP) = 60 mmHg ; PR = 60 bpm.
Exclusion criteria
Exclusion criteria: Any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs. - Subjects receiving concomitant treatment with other investigational drugs or having participated in another clinical trial within the previous 6 months before their inclusion in the study (i.e., ICF signature date). - Poor metabolizers for CYP2D6. - Previous or current COVID-19 disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the bioequivalence of Test and Reference formulations, in terms of total AUC(0-t) and Cmax of nebivolol and zofenopril when administered as fixed dose combination tablet (Test) and as extemporaneous two tablets combination (Reference). | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the pharmacokinetics of nebivolol and zofenopril in terms of other relevant secondary standard pharmacokinetic parameters such as AUC(0-8), plasma terminal half-life (t1/2), and time to peak plasma concentration (tmax) when nebivolol and zofenopril are administered as fixed-dose combination tablet and as extemporaneous two tablets combination. | — |
Countries
Germany
Contacts
Public ContactAngela Sinn
Parexel Early Phase Clinical Unit Berlin
Outcome results
None listed