A Study to Compare the Pharmacokinetics of Budesonide and Albuterol
Research type
Research Study
Full title
A Phase 1, Randomized, Open-label, Single-dose, 3-way Cross-over Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared with PT007 and PT008 Administered Separately (LOGAN)
IRAS ID
253828
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2018-003355-25
Duration of Study in the UK
0 years, 3 months, 20 days
Research summary
This is a Phase I, randomised, open-label, single-dose, 3-way cross-over study to be performed in healthy male and female volunteers at a single clinical centre. Females who are pregnant, nursing or trying to conceive will not be included in this study. This is not a first-in-human study. This means the study drugs studied in this research project have been given to humans before. In this study, the relative bioavailability will be investigated of budesonide and albuterol when administered individually and in combination via metered dose inhaler (MDI), to confirm appropriate systemic exposure (amount of study medication in the body). Bioavailability refers to the fraction of an administered dose of unchanged study medication that reaches the systemic blood circulation. The study will also see how safe budesonide and albuterol are after single doses of individual and combined formulations were taken. This study also yields an opportunity to confirm the lack of drug-drug interaction between budesonide and albuterol.
The study design allows for a screening visit, three treatment periods and a post-study visit 5 to 7 days after the last administration of study medication. Subjects will be randomised to one of 6 treatment sequences. The study will enrol 90 subjects to ensure that at least 81 subjects complete the study and have sufficient evaluable data.
The combination formulation (budesonide and albuterol [BDA]) is being developed by the sponsor to provide asthma patients with an as-needed reliever of tight chest and airway inflammation regardless of their regular maintenance therapy.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1687
Date of REC Opinion
14 Nov 2018
REC opinion
Further Information Favourable Opinion