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.
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