Back to resultsRelative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
terbutaline sulphate delivered dose
terbutaline sulphate metered dose
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers focused on measuring Healthy volunteers, pharmacokinetic, inhalation
Eligibility Criteria
Inclusion Criteria:
- Female and male volunteers aged between 18 and 65 years, both inclusive
- 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
- Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse
- 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:
- 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)
- Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded
- 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
- 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
- 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 -
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bricanyl Turbuhaler M3
Bricanyl Turbuhaler M2
Arm Description
0.4 mg terbutaline sulphate (delivered dose) per inhalation
0.5 mg terbutaline sulphate (metered dose) per inhalation
Outcomes
Primary Outcome Measures
Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]
These will be taken at each treatment period
Maximum Observed Plasma Concentration (Cmax)
These will be taken at each treatment period
Secondary Outcome Measures
Time to Reach Maximum Observed Plasma Concentration (Tmax)
These will be taken at each treatment period
Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)
These will be taken at each treatment period
Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]
These will be taken at each treatment period
Terminal Half-life (t1/2)
These will be taken at each treatment period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02178059
Brief Title
Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Healthy volunteers, pharmacokinetic, inhalation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bricanyl Turbuhaler M3
Arm Type
Experimental
Arm Description
0.4 mg terbutaline sulphate (delivered dose) per inhalation
Arm Title
Bricanyl Turbuhaler M2
Arm Type
Active Comparator
Arm Description
0.5 mg terbutaline sulphate (metered dose) per inhalation
Intervention Type
Drug
Intervention Name(s)
terbutaline sulphate delivered dose
Other Intervention Name(s)
Turbuhaler New Version
Intervention Description
0.4 mg terbutaline sulphate (delivered dose) per inhalation
Intervention Type
Drug
Intervention Name(s)
terbutaline sulphate metered dose
Other Intervention Name(s)
Turbuhaler Current Version
Intervention Description
0.5 mg terbutaline sulphate (metered dose) per inhalation
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]
Description
These will be taken at each treatment period
Time Frame
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Title
Maximum Observed Plasma Concentration (Cmax)
Description
These will be taken at each treatment period
Time Frame
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Secondary Outcome Measure Information:
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description
These will be taken at each treatment period
Time Frame
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Title
Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)
Description
These will be taken at each treatment period
Time Frame
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Title
Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]
Description
These will be taken at each treatment period
Time Frame
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Title
Terminal Half-life (t1/2)
Description
These will be taken at each treatment period
Time Frame
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female and male volunteers aged between 18 and 65 years, both inclusive
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
Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse
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:
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)
Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded
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
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
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amitava Ganguli, MB ChB, MRCP
Organizational Affiliation
Quintiles London United Kingdom
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Göran Eckervall, MD
Organizational Affiliation
Astrazeneca Mölndal, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ola Beckman, MD
Organizational Affiliation
Astrazeneca Mölndal, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2
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