Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study (COGUSS)
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|ClinicalTrials.gov Identifier: NCT02572375|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : March 29, 2017
The objectives of this pivotal study are:
- to evaluate bioavailability of an extended-release and immediate release Codeine Phosphate/Guaifenesin tablet at steady state following multiple oral administration
- to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended release formulation.
|Condition or disease||Intervention/treatment||Phase|
|Cough||Drug: Codeine Phosphate/Guaifenesin ER Tablet Drug: Codeine Phosphate/Guaifenesin IR Tablet||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||January 2015|
Experimental: Codeine Phosphate/Guaifenesin ER Tablet
Patients receiving an extended release tablet dosage form of a combination drug of Codeine Phosphate and Guaifenesin twice a day for 6 and a half days total. Total dosage [2 tablets] is 60 mg Codeine Phosphate and 1200 mg Guaifenesin twice a day for a daily total of 120 mg Codeine Phosphate and 2400 mg Guaifenesin.
Drug: Codeine Phosphate/Guaifenesin ER Tablet
Provide two Codeine Phosphate and Guaifenesin ER Tablet every 12 hours for 6 1/2 days.
Other Name: Lot 100171
Active Comparator: Codeine Phosphate/Guaifenesin IR Tablet
Patients receiving an immediate release tablet dosage form of a combination drug of Codeine Phosphate and Guaifenesin six times a day for 6 and a half days total. Dosage is 20 mg Codeine Phosphate and 400 mg Guaifenesin six times a day for a daily total of 120 mg Codeine Phosphate and 2400 mg Guaifenesin.
Drug: Codeine Phosphate/Guaifenesin IR Tablet
Provide one Codeine Phosphate and Guaifenesin IR Tablet every 4 hours for 6 1/2 days
Other Name: Lot 100168
- Peak Plasma Concentration (Cmax) [ Time Frame: One week ]Determination peak plasma concentration of each active ingredient during 12 hours following six days of dosing
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: One week ]Determination of total area under the plasma concentration versus time curve (AUC) during the 12 hours following 6 days of dosing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572375
|Pharmaceutical Research Unit|
|Amman, Jordan, 11910|
|Principal Investigator:||Rana T Bustami, PhD||Pharmaceutical Research Unit, Jordan|