Effects on the cardiovascular functions, thermoregulation and blood flow during microgravity
Conditions
Interventions
Trade Name: Nebilet
Product Name: Nebilet
Pharmaceutical Form: Tablet
INN or Proposed INN: Nebivolol
CAS Number: 118457-14-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Berlin-Chemie AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Male or female 3. Age 20 - 45 years 4. The subject is healthy as judged by the responsible physician, with no clinically significant abnormality identified during the screening evaluation or medical history, including ECG 5. Non-smoker 6. The subject is willing and able to participate in both study parts (tilting-table part and parabolic flight part) 7. Positive standard medical check-up for parabolic flight 8. The subject has a normal cardiovascular adjustment during tilting-table tests 9. The subject is willing to restrain a normal fluid supply before the tilting-table tests without a subjective feeling of thirst 10. The subject is able and willing to understand and comply with the requirements, restrictions and instructions defined in the trial protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has a concomitant illness and/or nebivolol and/or scopolamine specific contraindications apply: - Liver insufficiency or liver function impairment - Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy - Sick sinus syndrome, including sino-atrial block - Second and third degree heart block - History of bronchospasm and bronchial asthma - Untreated phaeochromocytoma - Metabolic acidosis - Bradycardia (heart rate < 60 bpm prior to start of treatment) - Hypotension (systolic blood pressure < 90 mmHg) - Severe peripheral circulatory disturbances - Narrow-angle glaucoma - Prostatic hypertrophy in male subjects - Pyloric obstruction 2. Known idiosyncrasy (hypersensitivity) to nebivolol and/or scopolamine or to any of the ingredients of the study drugs, or any known hypersensitivity to beta-blocker and/or anti-cholinergic drugs 3. Known motion sickness 4. Known fear of flying and/or abnormal nervousness 5. The subject is participating or has participated within the previous three months in a clinical study with an investigational or a non-investigational drug or device 6. The subject has participated in more than three studies within the past year 7. The subject is using any prescription or non-prescription drugs, vitamins, herbal and dietary supplements (including St John's Wort) within seven days or five half lives (which-ever is the longer) prior to the first dose of study medication 8. Clinically relevant symptoms within seven days prior to start of study 9. Any condition (surgical or medical) which will affect absorp-tion, distribution, metabolism and/or excretion of the study drug 10. Need for continuous medical treatment within seven days or five half lives (whichever is longer) prior to or during the study with the exception of contraceptives and scopolamine for prevention of motion sickness 11. History or presence of alcohol or substance abuse 12. Alcohol intake 24 hours prior to or during study visits 13. Regular consumption of large amounts of caffeine-containing beverages (equivalent to more than six cups of coffee per day) 14. Pregnancy or lactation 15. Female subjects not willing to use appropriate contraceptive measures for the duration of the study and for at least one month after the last dose of study drug. Medically accept-able contraceptives include e.g.: (1) surgical sterilization, (2) approved hormonal contraceptives, (3) 3-months injection, (4) combined oral methods (combination of methods with a gel, spray, foam, salve or suppository), (5) some kind of loop. Sexual abstinence or vasectomy of the partner are also acceptable measures to avoid pregnancy 16. The subject has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of the study is to generate first data about the options to use a beta-blocker in space in order to make some recommendations for a Space Pharmacopoeia. The primary objective is to investigate possible influences of nebivolol on intra-individual changes of microcirculation measured on temple and shinbone (tibia) under simulated and real micro-g conditions. ;Secondary Objective: Influences of nebivolol on heart rate, blood pressure, ECG and facial heat distribution. Moreover a standard model for drug testing under micro-g conditions will be investigated. ;Primary end point(s): Intra-individual changes of microcirculation under nebivolol or placebo. | — |
Countries
France
Outcome results
None listed