Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2

NCT ID: NCT02178059

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2014-11-30

Brief Summary

Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version

Detailed Description

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bricanyl Turbuhaler M3

0.4 mg terbutaline sulphate (delivered dose) per inhalation

Group Type: EXPERIMENTAL

terbutaline sulphate delivered dose

Intervention Type: DRUG

0.4 mg terbutaline sulphate (delivered dose) per inhalation

Bricanyl Turbuhaler M2

0.5 mg terbutaline sulphate (metered dose) per inhalation

Group Type: ACTIVE_COMPARATOR

terbutaline sulphate metered dose

Intervention Type: DRUG

0.5 mg terbutaline sulphate (metered dose) per inhalation

Interventions

terbutaline sulphate delivered dose

0.4 mg terbutaline sulphate (delivered dose) per inhalation

Intervention Type: DRUG

terbutaline sulphate metered dose

0.5 mg terbutaline sulphate (metered dose) per inhalation

Intervention Type: DRUG

Other Intervention Names

Turbuhaler New Version; Turbuhaler Current Version

Eligibility Criteria

Inclusion Criteria

1. Female and male volunteers aged between 18 and 65 years, both inclusive

2. Healthy as judged by the Principal Investigator after medical history, physical examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C antibody tests) and assessments of pulse rate and blood pressure

3. Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse

4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg -

Exclusion Criteria

1. History or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy)

2. Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded

3. Plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 mL during the 3 months prior to screening

4. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Principal Investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose

5. Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit 1) or on admission to the study centre (Day -1) prior to administration of the investigational medical product (IMP) on Day 1 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amitava Ganguli, MB ChB, MRCP

Role: PRINCIPAL_INVESTIGATOR

Quintiles London United Kingdom

Göran Eckervall, MD

Role: STUDY_DIRECTOR

Astrazeneca Mölndal, Sweden

Ola Beckman, MD

Role: STUDY_CHAIR

Astrazeneca Mölndal, Sweden

Locations

Research Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

D4711C00002

Identifier Type: -

Identifier Source: org_study_id