Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via Turbuhaler M3 with Turbuhaler M2

Study identifier:D4711C00002

ClinicalTrials.gov identifier:NCT02178059

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-label, Single-dose, 2-period Cross over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler Compared with the M2 Turbuhaler

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

terbutaline sulphate delivered dose, terbutaline sulphate metered dose

Sex

All

Actual Enrollment

34

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Aug 2014
Primary Completion Date: 01 Nov 2014
Study Completion Date: 01 Nov 2014

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria