CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Humibid® +2 moredrug
Likely dose
Guaifenesin (Humibid) 1200 mg single dose plus hydrocodone bitartrate 3.33 mg every 4 hours for 3 dosesAI-extracted
Key inclusion· 6
  • ✓Age 19-55 years
  • ✓Good general health on physical exam, ECG, and lab work
  • ✓Within 15% of ideal body weight
  • ✓Non-tobacco user for ≥1 year
Key exclusion· 8
  • ✕Clinically significant abnormalities on exam, ECG, or labs, or conditions affecting drug absorption, distribution, metabolism, or elimination
  • ✕Hypersensitivity reaction to guaifenesin, hydrocodone, or other opioids
  • ✕Recent blood or plasma donation (within 56 days for blood, 14 days for plasma)
  • ✕Known or suspected use of illicit drugs, codeine, or hydrocodone

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03642873
NCT03642873Phase 1Completed
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A Study Designed to Examine the Potential for a Drug-drug Interaction Between Guaifenesin and Hydrocodone Bitartrate in Normal Healthy Volunteers

Reckitt Benckiser LLC·interventional·Posted Aug 22, 2018·Updated Jun 20, 2019

In Brief

A Phase 1 clinical trial evaluating Humibid®, Hydrocodone Bitartrate, and 1 other intervention for Healthy Subjects. Completed, enrolled 24 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Subjects
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 22, 2018
Enrollment StartMay 5, 2007
Primary CompletionMay 21, 2007
TodayJul 2, 2026
Enrollment to primary: 16 daysPosted 7.9 years ago

Interventions

Humibid®drug

Humibid® 1200 mg (single extended release) tablet

Hydrocodone Bitartratedrug

Hydrocodone Bitartrate (3.33 mg q4h X 3)

Humibid® and Hydrocodone Bitartrate tabletdrug

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