NCT02157649

Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

An Open-Label, Single-Dose, Crossover Comparative Bioavailability and Pharmacokinetic Study of Codeine Phosphate/Guaifenesin Extended-Release Tablet With Immediate-Release Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Nexgen Pharma, Inc · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are (a) to determine if drug levels from a single dose of an extended-release Codeine/Guaifenesin tablet are similar to an immediate-release tablet given every four hours containing lower doses considered safe for over-the-counter use; (b) to evaluate if food affects the drug levels of this extended-release Codeine/Guaifenesin tablet after a single administration; and (c) to assess the safety and tolerability of the Codeine/Guaifenesin extended-release and immediate release tablet formulations.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	IR Tablet under Fasted conditions	Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.
DRUG	ER Tablet under Fed Conditions	Administration of two ER Tablet combination of Codeine Phosphate/Guaifenesin 30mg/600mg
DRUG	ER Tablet under Fasted Conditions	Administration of two Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablets under fasted conditions.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2014-06-06
• Last updated: 2015-04-15

Locations

1 site across 1 country: Jordan