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Study to Evaluate Drug-drug Interactions of Guaifenesin and Hydrocodone Bitartrate

NCT03642873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-06-20

Study results available
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Summary

Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

Humibid®

Humibid® 1200 mg (single extended release) tablet

DRUG

Hydrocodone Bitartrate

Hydrocodone Bitartrate (3.33 mg q4h X 3)

DRUG

Humibid® and Hydrocodone Bitartrate tablet

Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-05
Primary Completion
2007-05-21
Completion
2007-05-21
FDA Drug
Yes

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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 NCT03642873 on ClinicalTrials.gov