NCT03643575

Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.

A Phase I, Open- Label, Randomized, Multiple-dose, 3-way Crossover Relative Bioavailability Study to Characterize the Pharmacokinetics of the 3 Marketed Products Containing 200 mg Guaifenesin Under Fasted Conditions in Normal Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Reckitt Benckiser Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Vicks Cough Syrup for Chesty Coughs	Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
DRUG	Robitussin Extra Strength Chest Congestion	Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
DRUG	Organ-I- NR tablet	Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water

Timeline

• Start date: 2009-06-30
• Primary completion: 2009-07-16
• Completion: 2009-07-16
• First posted: 2018-08-23
• Last updated: 2019-03-27
• Results posted: 2019-02-22

Regulatory

• FDA-regulated drug study