Not applicable, this is s Bioequivalence study Not Applicable
Conditions
Interventions
The following visits were performed:
Screening phase
-Screening – visit 1: between Day -14 and Day -2
-Period 1 – visit 2: Day -1
Interv
Sponsors
Neopharmed Gentili S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: males/females, 18-55 year old inclusive 3. Body Mass Index (BMI): 18.5-28 kg/m2 inclusive 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 60-89 mmHg, heart rate (HR) 50-90 bpm, measured after 5 min at rest in the sitting position 5. Body temperature: 35.7-37.5° C at screening 6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study 7. Contraception and fertility (females): females of child-bearing potential had to be using at least one of the following reliable methods of contraception: a. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit b. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit c. A male sexual partner who agrees to use a male condom with spermicide d. A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, pregnancy test result had to be negative at screening. 8. Contraception (males): males with partners of childbearing potential had to either be sterile or agree to use one of the following approved methods of contraception from the first study drug administration until at least 45 days after the last administration: a. A male condom with spermicide b. A sterile sexual partner or a partner in post-menopausal status for at least 1 year c. Use by the female sexual partner of an IUD, a female condom with spermicide, a contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit 9. Male subjects had to accept to inform their partners of the participation in the clinical study
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings indicative of physical illness 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Virology: positive result of serum virology assays 5. Allergy: ascertained or presumptive hypersensitivity to the active principles and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study 6. Hypotension and heart rate: during the screening procedures or history of orthostatic hypotension or syncope/fainting or HR1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day) 12. Drug test: positive result at the drug test at screening 13. Alcohol test: positive alcohol breath test at day -1 14. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 15. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women 16. Previous study: participation in previous trials of ramipril/bisoprolol alone or in a fixed dose combination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bioequivalent rate (Cmax) and extent (AUC0-48h) of absorption of ramipril and bisoprolol after single dose administration of test and reference products. Plasma concentrations were evaluated using an LC/MS-MS assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The plasma PK profile (0-48h) of ramipril and bisoprolol after single dose administration of test and reference products. Plasma concentrations were evaluated using an LC/MS-MS assay. 2. Safety and tolerability of test and reference products after single dose administration were evaluated in both study periods using patient notes. | — |
Countries
Switzerland
Outcome results
None listed