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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Terbutaline

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 -