NCT03642873

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

A Study Designed to Examine the Potential for a Drug-drug Interaction Between Guaifenesin and Hydrocodone Bitartrate in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Reckitt Benckiser LLC · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2007-05-05
• Primary completion: 2007-05-21
• Completion: 2007-05-21
• First posted: 2018-08-22
• Last updated: 2019-06-20
• Results posted: 2019-06-20

Regulatory

• FDA-regulated drug study