Echocardiographic Study of a Single Dose Bisoprolol Versus Nebivolol in Healthy Subjects (BINEB)

Clinical Hospital Center Zemun

Status and phase: Withdrawn; Phase 4

Conditions: Nebivolol Adverse Reaction; Bisoprolol Adverse Reaction

Treatments: Drug: Bisoprolol versus Nebivolol

Study type: Interventional

Funder types: Other

Identifiers

NCT04432610

01-2020

Details and patient eligibility

About

This is a randomized, double-blind, crossover study in healthy adult subjects. Each subject will receive a single dose of bisoprolol 5 mg p.o. and nebivolol 5 mg p.o. with 1 week washout period. All subjects will undergo a physical examination, 12-lead electrocardiography and a comprehensive echocardiographic study before the administration of the study drug and 5 hours thereafter.

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects (male and female)
2. Age interval: 20-60 years old (inclusive)

Exclusion criteria

1. Any known absolute or relative contraindication to beta-blocker therapy
2. Poor echogenicity
3. A resting heart rate <60 bpm
4. A resting blood pressure < 110/70 mmHg

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

Bisoprolol first, Nebivolol Second

Experimental group

Description:

In this arm, patient will first receive bisoprolol, and after 1 week washout period, nebivolol

Treatment:

Drug: Bisoprolol versus Nebivolol

Nebivolol first, Bisoprolol second

Experimental group

Description:

In this arm, patient will first receive nebivolol, and after 1 week washout period, bisoprolol

Treatment:

Drug: Bisoprolol versus Nebivolol