NCT02688361

A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution

A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study in Healthy Adult Subjects After Single Oral Dosing of a NCH-GSK Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil® Acetylcysteine 2% Oral Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants. Eligible participants will receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N- acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution, 200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in each period. After completion of the second study period (i.e. last pharmacokinetic (PK) sample on Day 3 of Period 2) participants will be discharged from the clinic.

Conditions

• Infections, Respiratory Tract

Interventions

Type	Name	Description
DRUG	Fluimucil® 2% solution	Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference).
DRUG	Acetylcysteine 2% solution	Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test)

Timeline

• Start date: 2016-02-22
• Primary completion: 2016-04-13
• Completion: 2016-04-13
• First posted: 2016-02-23
• Last updated: 2019-01-24

Locations

1 site across 1 country: Germany