Phase 1
Completed N=34
Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2
Healthy Volunteers
Source: ClinicalTrials.gov NCT02178059 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)] — 89.04; 100.9 nmol*h/L
Summary
Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)] |
89.04; 100.9 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
12.00; 13.12 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
1.33; 1.33 | 0.8052 |
| SECONDARY Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) |
96.63; 109.7 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)] |
89.0; 101 | — |
| SECONDARY Terminal Half-life (t1/2) |
11.7; 11.8 | — |
Eligibility Criteria
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 -
Data sourced from ClinicalTrials.gov (NCT02178059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.