In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
NCT05429775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2022-06-23
Summary
This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
Budesonide
single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Sandoz · Sandoz
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 30 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-26
- Primary Completion
- 2019-01-29
- Completion
- 2019-01-29
Countries
- United Kingdom
Study Locations
More Related Trials
-
Budesonide / Formoterol in Treatment of Exacerbations of COPD
NCT00239278 ·Status: COMPLETED ·Phase: PHASE2
-
This Study in Healthy Men Tests How Different Doses of BI 1265162 Are Taken up in the Body and How Well They Are Tolerated.
NCT03576144 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
NCT07267130 ·Status: RECRUITING ·Phase: PHASE1
-
Efficacy Study of the Effect of Budesonide on Emphysema
NCT00232674 ·Status: COMPLETED ·Phase: PHASE4
-
Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol
NCT01555099 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
NCT03740373 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Inhalative Doses of BEA 2180 BR in Healthy Male Volunteers
NCT02254122 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Rising of BEA 2180 BR in Japanese Healthy Male Volunteers
NCT02254109 ·Status: COMPLETED ·Phase: PHASE1
-
The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis
NCT01769898 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Pilot Study on Budesonide/Formoterol
NCT01457716 ·Status: COMPLETED ·Phase: NA
-
Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell Transplantation
NCT01560689 ·Status: COMPLETED ·Phase: PHASE2
-
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
NCT01817855 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers
NCT01762774 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
NCT01921712 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
NCT01023516 ·Status: COMPLETED ·Phase: PHASE2
-
Chronicling the COPD Patient Journey and Change in COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF]
NCT06511193 ·Status: ACTIVE_NOT_RECRUITING
-
Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia
NCT00005880 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
NCT02386761 ·Status: COMPLETED ·Phase: PHASE1
-
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01233232 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
NCT05477108 ·Status: COMPLETED ·Phase: PHASE1
-
A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD
NCT02986321 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers
NCT02359292 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
NCT01153321 ·Status: COMPLETED ·Phase: PHASE2
-
Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
NCT00932646 ·Status: COMPLETED ·Phase: PHASE3
-
A Scintigraphy Study of PT010 in COPD Patients
NCT03906045 ·Status: COMPLETED ·Phase: PHASE1