Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Turbuhaler New Version
terbutaline sulphate delivered dose · 1 trial · 1 indication
These will be taken at each treatment period
These will be taken at each treatment period
| 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 |
| 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 |
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...
Terbutaline sulphate delivered dose is an inhaled small molecule formulation of terbutaline sulphate developed by AstraZeneca PLC. It was studied in a Phase 1 relative bioavailability trial comparing delivery via the Turbuhaler M3 device with the Turbuhaler M2 device in healthy adult volunteers in the United Kingdom.
Terbutaline sulphate delivered dose targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor. The drug is a small molecule administered by inhalation, and the Phase 1 program evaluated the delivered dose from two different Turbuhaler device versions.
AstraZeneca PLC (ticker AZN) is the developer of terbutaline sulphate delivered dose. The company sponsored the Phase 1 relative bioavailability study NCT02178059, which compared inhalation of terbutaline sulphate 1.5 mg via Turbuhaler M3 with Turbuhaler M2 in healthy volunteers.
Terbutaline sulphate delivered dose is in Phase 1 development. The only listed trial, NCT02178059, is a completed Phase 1 relative bioavailability study. No Phase 2 or later trials are recorded, so the asset remains investigational and has not been approved for any indication based on the available development record.
Terbutaline sulphate delivered dose has been studied in one clinical trial, NCT02178059, titled Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2. The trial was Phase 1, completed, randomized, active controlled, enrolled 34 healthy volunteers in the United Kingdom, and had no biomarker selection.