A double blind, randomized, cross-over, placebo controlled study, evaluating the time-to-onset of action of BLX000441-002 nasal spray in healthy volunteers. - Time to Onset

Biolipox AB0 个研究点目标入组 12 人开始时间: 2004年10月6日最近更新: 2012年3月19日

研究概览

暂无简介。

•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

•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

发起方