Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single Centre, Open-label, 5-Period, Cross Over, Randomized Study in Healthy Elderly Subjects to Evaluate the Relative Bioavailability of Hydrobromide Salt and Free Base Immediate Release Tablet Formulations of Danirixin in the Fed State, and to Evaluate the Effect of Food and Gastric Acid Secretion Suppression on Danirixin Pharmacokinetics Following Administration of Hydrobromide Salt Tablets
The current study will help to increase our understanding of the pharmacokinetics (PK) of
danirixin. The primary objective of the study is to estimate the relative bioavailability of
danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and
tolerability information for oral administration of danrixin HBr tablets in elderly subjects
will also be obtained. Secondarily, this study will evaluate effect of food on PK of
danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of
danirixin HBr. The outcome of this study will contribute to the selection of the most
appropriate formulation/dosing regimen for future studies.
This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy
elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The
Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will
be done within 3 to 10 days post last dose.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
| Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
| Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
| Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
| Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
| Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
| Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
| Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
| Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
| Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
| Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
| Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
| Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
| Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
| Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
| Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|