Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: BDP HFA Inhalation Aerosol (QVAR); Drug: BDP HFA Nasal Aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537692

BDP-AR-101

Details and patient eligibility

About

The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed Consent
• Male or female subjects 18-45 years of age
• General good health

Exclusion criteria

• History of physical findings of nasal pathology (within 60 days prior to Screening Visit)
• Participation in any investigational drug study 30 days preceding Screening Visit
• History of respiratory infection/disorder with 28 days preceding Screening Visit

Trial design

30 participants in 3 patient groups

BDP HFA Nasal Aerosol 80 mcg/d

Experimental group

Description:

single dose, intranasal aerosol

Treatment:

Drug: BDP HFA Nasal Aerosol

Drug: BDP HFA Nasal Aerosol

BDP HFA Nasal Aerosol 320 mcg/d

Experimental group

Description:

single dose, intranasal aerosol

Treatment:

Drug: BDP HFA Nasal Aerosol

Drug: BDP HFA Nasal Aerosol

BDP HFA Inhalation Aerosol 320 mcg/d

Active Comparator group

Description:

single dose, orally inhaled aerosol

Treatment:

Drug: BDP HFA Inhalation Aerosol (QVAR)