healthy volunteers
Conditions
Interventions
Product Name: Cetirizine dinitrate
Product Code: BLX000441-002
Pharmaceutical Form: Nasal spray*
INN or Proposed INN: cetirizine dinitrate
Current Sponsor code: BLX000441-002
Other descriptive name: (
Sponsors
Biolipox AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the study obtained 2. Male or female subject aged 18-50 years, extremes included 3. Body Mass Index between 18 and 28 kg/m2 , extremes included 4. Good age-related health condition as judged by the investigator and established by medical history and physical examination at the screening visit. 5. Negative skin prick test 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. Known hypersensitivity to cetirizine or any of the other compounds of the investigational products 2. Positive screen for HIV, Hepatitis B and/or C 3. Current smoker, or a history of smoking more than 10 cigarettes a day over a period of at least 5 years. 4. Soy bean and peanut allergy. 5. Therapy with any drug (for two weeks preceding dosing) except for occasional analgesics and hormonal contraceptives 6. Relevant history of or current condition that in the opinion of the investigator might interfere with the therapeutic effect of the investigational product. 7. History of or current abuse of drugs or alcohol or solvents 8. Women who are pregnant, lactating or likely to become pregnant during the course of the study, or women of child bearing potential not using adequate contraception (i.e. hormonal contraception or barrier methods) 9. Participating in any other investigational study in the last 30 days 10. Subject not able to communicate with the investigator 11. Inability to adhere to study plan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: BLX000441-002 is intended for the treatment of seasonal allergic rhinitis. The primary objective in this study is to evaluate the time-to-onset of action of BLX000441-002 nasal spray compared with placebo, as measured by alfa2-macroglobulin levels, after a single dose in healthy volunteers ;Secondary Objective: The secondary objectives are: - to evaluate the Total Nasal Symptom Score of BLX000441-002 nasal spray compared with placebo after a single dose in healthy volunteers - to evaluate the safety of BLX000441-002 nasal spray ;Primary end point(s): Alfa2-macroglobulin is used as a measure of the amount of plasma exudation after, in this study, a histamine challenge | — |
Countries
Sweden
Outcome results
None listed