NCT02572375

Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study

An Open-Label, Randomized, Multiple-Dose, 2-Way Crossover Comparative Bioavailability Steady State Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Nexgen Pharma, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Codeine Phosphate/Guaifenesin ER Tablet	Provide two Codeine Phosphate and Guaifenesin ER Tablet every 12 hours for 6 1/2 days.
DRUG	Codeine Phosphate/Guaifenesin IR Tablet	Provide one Codeine Phosphate and Guaifenesin IR Tablet every 4 hours for 6 1/2 days

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-11-01
• Completion: 2015-01-01
• First posted: 2015-10-08
• Last updated: 2017-03-29

Locations

1 site across 1 country: Jordan