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terbutaline sulphate delivered dose

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 1, 2017

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED

Total Trials1

Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

terbutaline sulphate delivered dose · 1 trial · 1 indication

Phase 1 1

NCT02178059Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2Healthy Volunteers

COMPLETED34 Analytics

PHASE1COMPLETED

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

Healthy Volunteers

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Study Endpoints

Primary Endpoints

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 Endpoints

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

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeBASIC_SCIENCE

Treatment Arms

Arm	Type	Description
Bricanyl Turbuhaler M3	EXPERIMENTAL	0.4 mg terbutaline sulphate (delivered dose) per inhalation
Bricanyl Turbuhaler M2	ACTIVE_COMPARATOR	0.5 mg terbutaline sulphate (metered dose) per inhalation

Interventions

Name	Type	Description
terbutaline sulphate delivered dose	DRUG	0.4 mg terbutaline sulphate (delivered dose) per inhalation
terbutaline sulphate metered dose	DRUG	0.5 mg terbutaline sulphate (metered dose) per inhalation

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Eligibility Criteria

Age Range18 Years to 65 Years

SexALL

Healthy VolunteersYes

Study Sites1

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...

Countries:United Kingdom

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Frequently asked questions about terbutaline sulphate delivered dose

What is terbutaline sulphate delivered dose used for?

Terbutaline sulphate delivered dose is an investigational small molecule being studied in healthy volunteers. It is administered by inhalation and is being evaluated in a clinical trial to compare the relative bioavailability of different inhaler devices. The drug is in Phase 1 clinical development.

Who makes terbutaline sulphate delivered dose?

Terbutaline sulphate delivered dose is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this inhaled small molecule in healthy volunteers.

What phase is terbutaline sulphate delivered dose in?

Terbutaline sulphate delivered dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to study its bioavailability when inhaled.

What clinical trials is terbutaline sulphate delivered dose in?

Terbutaline sulphate delivered dose has one completed clinical trial, identified as NCT02178059. This Phase 1 study, titled "Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2," enrolled 34 participants in the United Kingdom.

Is terbutaline sulphate delivered dose the same as terbutaline sulphate?

Terbutaline sulphate delivered dose is a formulation of terbutaline sulphate, a small molecule bronchodilator. The "delivered dose" designation refers to the amount of drug that is delivered from the inhaler device. The clinical trial compares different inhaler devices delivering terbutaline sulphate.