Recent Updates
Recently added Catalysts

terbutaline sulphate delivered dose

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02178059Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2PHASE1 COMPLETED 34 — — Aug 1, 2014Nov 1, 2014Mar 1, 20171 United Kingdom
Unlock Drug Trial Details
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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Bricanyl Turbuhaler M3EXPERIMENTAL0.4 mg terbutaline sulphate (delivered dose) per inhalation
Bricanyl Turbuhaler M2ACTIVE_COMPARATOR0.5 mg terbutaline sulphate (metered dose) per inhalation
Interventions
NameTypeDescription
terbutaline sulphate delivered doseDRUG0.4 mg terbutaline sulphate (delivered dose) per inhalation
terbutaline sulphate metered doseDRUG0.5 mg terbutaline sulphate (metered dose) per inhalation
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria