Cough Clinical Trial
Official title:
An Open-Label, Randomized, Multiple-Dose, 2-Way Crossover Comparative Bioavailability Steady State Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet in Healthy Subjects
The objectives of this pivotal study are:
1. to evaluate bioavailability of an extended-release and immediate release Codeine
Phosphate/Guaifenesin tablet at steady state following multiple oral administration
2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended
release formulation.
This study will be a single-center, Two-site open-label, randomized, multiple-dose,
two-treatment, two-period crossover design. During the course of the study, thirty eight
(38) healthy adult volunteers will receive multiple doses of Codeine Phosphate/ Guaifenesin
extended-release tablet 30 mg/600 mg and multiple doses of an IR Codeine Phosphate/
Guaifenesin immediate-release tablet 20 mg/400 mg tablet in two separate treatment periods.
Volunteers will enter the clinic the day prior [approximately 12 hours] to each dosing and
will be confined in the clinic for 7 nights for each treatment period. The extended release
tablet (test) will be administered as two tablets two times a day, 12 hours apart, and the
immediate release tablet (reference) will be administered as one tablet six times a day, 4
hours apart. Pre-dose blood samples will be collected prior to morning dose on Days 1, 2, 3,
4, 5, 6 and 7. On Day 7, Two extended release tablets will be given once in the morning and
the immediate release tablet will be given three times, in the morning and 4 and 8 hours
later. Serial blood samples will be collected on Day 7 for up to 12 hours post morning dose.
On Day 7 volunteers will be released from the study site after the 12-hour blood collection
if clinically appropriate and will return to the study site to start the next treatment
after a minimum of 7 days of wash-out period, which begins the morning after the last dose
taken of the previous Period.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Not yet recruiting |
NCT04064333 -
Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care
|
N/A | |
Recruiting |
NCT02482818 -
Efficacy of Pregabalin on Chronic Cough
|
Phase 1/Phase 2 | |
Terminated |
NCT02269761 -
Chest Ultrasound of ER Patients With Cough or SOB
|
||
Active, not recruiting |
NCT02065440 -
The Effect of Ebastine/Pseudoephedrine on Subacute Cough
|
N/A | |
Completed |
NCT01071161 -
The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough
|
Phase 3 | |
Completed |
NCT00353951 -
An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care
|
N/A | |
Terminated |
NCT00668317 -
Bronchial Hyper-responsiveness in Reflux Cough
|
Phase 3 | |
Completed |
NCT00287339 -
The Utility of Nexium in Chronic Cough and Reflux Disease
|
Phase 4 | |
Completed |
NCT00127686 -
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
|
Phase 1 | |
Recruiting |
NCT05115097 -
AI Evaluation of COVID-19 Sounds (AI-EChOS)
|
||
Recruiting |
NCT04457011 -
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
|
Phase 2 | |
Recruiting |
NCT05042063 -
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
|
||
Recruiting |
NCT03922373 -
A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects
|
Phase 1 | |
Completed |
NCT05812209 -
Stellate Ganglion Block to Treat Long COVID 19 Case Series
|
||
Recruiting |
NCT04767074 -
A Non-pharmacological Cough Control Therapy
|
N/A | |
Recruiting |
NCT05570539 -
Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation
|
Phase 1 | |
Completed |
NCT03999203 -
A Cross-sectional Study to Measure Cough in Severe Asthma
|
N/A | |
Active, not recruiting |
NCT05479929 -
Work of Breathing Assessment in Triage Scale
|
||
Recruiting |
NCT02495571 -
Assessment of Voluntary and Reflex Cough in Patients With ALS
|
N/A |