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

NCT02688361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-01-24

No results posted yet for this study

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

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)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-22
Primary Completion
2016-04-13
Completion
2016-04-13

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT02688361 on ClinicalTrials.gov