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

Phase 1

Completed

Interventions: Drug: terbutaline sulphate metered dose
Drug: terbutaline sulphate delivered dose

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)

Recruitment & Eligibility

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 -

Arm && Interventions

Group	Intervention	Description
Bricanyl Turbuhaler M2	terbutaline sulphate metered dose	0.5 mg terbutaline sulphate (metered dose) per inhalation
Bricanyl Turbuhaler M3	terbutaline sulphate delivered dose	0.4 mg terbutaline sulphate (delivered dose) per inhalation

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]	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	These will be taken at each treatment period
Maximum Observed Plasma Concentration (Cmax)	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	These will be taken at each treatment period

Secondary Outcome Measures

Name	Time	Method
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	These will be taken at each treatment period
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	These will be taken at each treatment period
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	These will be taken at each treatment period
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	These will be taken at each treatment period