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

NCT02572375 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-03-29

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Pharmaceutical Research Unit, Jordan

    collaborator OTHER

  • Nexgen Pharma, Inc

    lead INDUSTRY

Principal Investigators

  • Rana T Bustami, PhD · Pharmaceutical Research Unit, Jordan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-11-30
Completion
2015-01-31

Countries

  • Jordan

Study Locations

More Related Trials

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 NCT02572375 on ClinicalTrials.gov