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Single Dose Trial of Extended Release Combination Tablet Codeine and Guaifenesin

NCT02157649 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-04-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Nexgen Pharma, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Jordan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157649 on ClinicalTrials.gov