Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Current Version of Turbohailer With Inhalation Via a New Version.

Asthma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178059
• Other study ID #: D4711C00002
• Status: Completed
• Phase: Phase 1
• First received: June 27, 2014
• Last updated: November 19, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 -

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Drug:
• terbutaline sulphate delivered dose
0.4 mg terbutaline sulphate delivered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)
• terbutaline sulphate metered dose
0.5 mg terbutaline sulphate metered dose per inhalation, 3 inhalations comprise a single dose (for a total of 1.2 mg delivered dose)

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary pharmacokinetic (PK) measures will be described in terms of maximum observed plasma concentration (Cmax) and area under the curve ( AUC)	These will be taken at each treatment period	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	No
Secondary	The secondary PK measures will be described in terms of PK parameters will be time to reach maximum observed concentration (tmax)	These will be taken at each treatment period	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	No
Secondary	The secondary PK measures will be described in terms of area under the plasma concentration time curve from zero to the last quantifiable concentration [AUC(0 t)]	These will be taken at each treatment period	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	No
Secondary	The secondary PK measures will be described in terms of area under the plasma concentration time curve from zero to 36 hours postdose [AUC(0 36)]	These will be taken at each treatment period	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	No
Secondary	The secondary PK measures will be described in terms of terminal half-life (t1/2)	These will be taken at each treatment period	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	No
Secondary	Safety will be described in terms of adverse events, physical examination, safety laboratory and Electro cardiogram (ECG)		From the screening until follow up ( approximately 7-9 weeks)	Yes