Allergic Rhinitis Chronic Spontaneous Urticaria
Conditions
Interventions
Group B:Group B was assigned to receive the reference product (R) during Period 1 and the test product (T) during Period 2.
Group A:Group A was assigned to receive the test product (T) during Period 1 and the reference product (R) during Period 2.
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy males and non-pregnant/non-lactating females, aged 18–55 years (inclusive; those turning >55 during the study will not be excluded); 2. Body weight >=50.0 kg for males and >=45.0 kg for females, with BMI 19.0–26.0 kg/m^2 (inclusive); 3. Agreement to use effective contraception from screening to 3 months post-trial, with no pregnancy or gamete donation plans during this period; 4. Voluntary provision of written informed consent; 5. Ability to communicate well with investigators and comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial within 1 month; 2. Clinically significant diseases, especially renal insufficiency; 3. History of asthma or epilepsy; 4. History of allergy to the study drug, its excipients, or loratadine; 5. Current or history of severe oral diseases; 6. Taste or olfactory dysfunction; 7. Alcohol consumption >14 units/week within 3 months or inability to abstain; 8. Smoking >5 cigarettes/day within 3 months or inability to refrain; 9. Use of any medication or vaccination within 7 days; 10. Drug abuse history within 12 months; 11. Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG; 12. Positive pregnancy test or lactation; 13. Positive results for HBsAg, HCV Ab, HIV Ab, or syphilis; 14. Positive alcohol breath test; 15. Habitual betel nut chewing; 16. Failure of the Day -1 palatability assessment; 17. Poor compliance or any other condition deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall palatability VAS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS scores for the test formulation’s smell, sweetness, bitterness, and aftertaste; | — |
Countries
China
Contacts
Public ContactPeiwen Zhang
Deyang People's Hospital
Outcome results
None listed