Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Nexgen Pharma, Inc
Treatments:
Chlorpheniramine, phenylpropanolamine drug combination Codeine Guaifenesin Phenylpropanolamine