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

NCT02178059 | Completed Phase 1 Results

• 1 other identifier: D4711C00002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy volunteers, pharmacokinetic, inhalation

Outcome Measures

Primary Outcomes (2)

• 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

  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

• Maximum Observed Plasma Concentration (Cmax)

  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

Secondary Outcomes (4)

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  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

• Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)

  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

• Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]

  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

• Terminal Half-life (t1/2)

  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

Study Arms (2)

Bricanyl Turbuhaler M3

EXPERIMENTAL

0.4 mg terbutaline sulphate (delivered dose) per inhalation

Drug: terbutaline sulphate delivered dose

Bricanyl Turbuhaler M2

ACTIVE COMPARATOR

0.5 mg terbutaline sulphate (metered dose) per inhalation

Drug: terbutaline sulphate metered dose

Interventions

terbutaline sulphate delivered dose DRUG

0.4 mg terbutaline sulphate (delivered dose) per inhalation

Also known as: Turbuhaler New Version

Bricanyl Turbuhaler M3

terbutaline sulphate metered dose DRUG

0.5 mg terbutaline sulphate (metered dose) per inhalation

Also known as: Turbuhaler Current Version

Bricanyl Turbuhaler M2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Göran Eckerwall, Medical Science Director
• Organization: AstraZeneca R&D

Goran.Eckerwall@astrazeneca.com

1-800-236-9933

Study Officials

• Amitava Ganguli, MB ChB, MRCP

  Quintiles London United Kingdom

  PRINCIPAL INVESTIGATOR

• Göran Eckervall, MD

  Astrazeneca Mölndal, Sweden

  STUDY DIRECTOR

• Ola Beckman, MD

  Astrazeneca Mölndal, Sweden

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: June 30, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 1, 2017
• Results First Posted: August 2, 2016

Record last verified: 2017-01

Locations

GB (1)