Bioequivalence of Zofenopril and Nebivolol following their oral co-administration as fixed or extemporaneous combination in healthy volunteers. An open label, randomized, two periods, two sequences, cross-over study
- Conditions
- bioequivalence study in healthy subjects
- Registration Number
- DRKS00020911
- Lead Sponsor
- Menarini Ricerche S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 37
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.