Verification of allergic symptom-improving effects and adequate safety in vivo by spraying and inhaling test aerosol
- Conditions
- Healthy male/female adults
- Registration Number
- JPRN-UMIN000045784
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
(1) Subjects with current/previous medical history of serious diseases in respiratory system. (2) Throughout this trial, subjects who take steadily in affecting medicines/foods/supplements. (3) Subjects being under some kind of medical treatment, or planning to be treated during this trial. (4) Subjects with previous/current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Subjects with excessive alcohol intake. (6) Pregnant, possibly pregnant, and lactating women. (7) Subjects having a drug/chemical allergy. (8) Subjects being under another clinical test with medicines and/or health foods, or participated in that within four weeks before this trial, or planning to take part in that after giving informed consent to participate in this trial. (9) Subjects who are planning to be treated for allergic rhinitis, and take steadily in antiallergic oral medicines, during this trial. (10) All the year around, subjects who take steadily in oral medicines, eye drops and nasal spray, corresponding to antihistamines and antiallergics. (11) Throughout this trial, subjects who have any difficulty in refraining from inhaling another antiseptic aerosol, which might affect the test results. (12) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (13) Males who donated their whole blood (400 mL) within the last three months to this trial. (14) Females who donated their whole blood (400 mL) within the last four months to this trial. (15) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (16) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method