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

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

Detailed Description
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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)

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: terbutaline sulphate delivered dose
* Drug: terbutaline sulphate metered dose


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bricanyl Turbuhaler M3<br>0.4 mg terbutaline sulphate (delivered dose) per inhalation | Drug: terbutaline sulphate delivered dose<br>* 0.4 mg terbutaline sulphate (delivered dose) per inhalation<br>* Other names: Turbuhaler New Version;|
| Active Comparator: Bricanyl Turbuhaler M2<br>0.5 mg terbutaline sulphate (metered dose) per inhalation | Drug: terbutaline sulphate metered dose<br>* 0.5 mg terbutaline sulphate (metered dose) per inhalation<br>* Other names: Turbuhaler Current Version;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Plasma 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 | 
| Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, pharmacokinetic, inhalation