An open-label, randomized, single center, single dose compared pharmacokinetic study of Azelastine Hydrochloride Fluticasone Propionate Nasal Spray

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025389

Enrollment

Unknown

Registered

2019-08-25

Start date

2019-08-22

Completion date

Unknown

Last updated

2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Interventions

Experimental group:Azelastine Hydrochloride Fluticasone Propionate Nasal Spray

control group:Approved Azelastine Hydrochloride Fluticasone Propionate Nasal Spray

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Healthy male chinese volunteers aged from 18 to 40 and with a body mass index between 19–24 kg/m2; a healthy status confirmed by medical history, physical examination, 12-lead ECG, and laboratory tests (hematology, blood biochemistry, hepatic function, urinalysis, hepatitis B surface antigen, tests for alcohol and other drugs of abuse) and nonsmoking status.

Exclusion criteria

Exclusion criteria: any allergic history or history of cardiac, pulmonary, renal, hepatic, gastrointestinal or hematologic abnormality or any other acute or chronic disease. exposure to any investigational medication within 30 days of the first dose of study medication.

Design outcomes

Primary

Measure	Time frame
plasma drug concentration;	—

Countries

China

Contacts

Public ContactLuo Zhu

West China Hospital, Sichuan University

luozhu720@163.com+86 028-85421606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026