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A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02688361•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments.
•Male and female participants of any ethnic origin between 18 and 45 years of age. Body Mass Index (BMI) of 18.5 to 30 kg/m2, inclusive. Minimal body weight of 50 kg, inclusive.
•Normal vital signs as follows: Oral body temperature between 35.0 and 37.5 ºC inclusive; Sitting systolic blood pressure between 90 and 140 mmHg inclusive; Sitting diastolic blood pressure between 55 and 90 mmHg inclusive; Sitting pulse rate between 50 and 100 bpm inclusive.
•In general, good physical health, as judged by the Investigator and determined by medical/surgical history, physical examination, electrocardiogram (ECG, 12-lead) and clinical laboratory (clinical chemistry and hematology) findings.

Exclusion Criteria

•Use of other investigational drugs within 3 months or 10 half-lives of enrollment, whichever is longer.
•History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical or pharmacological classes.
•Diagnosis of long QT syndrome or QTc (Fridericia preferred, but Bazett acceptable) ≥ 450 msec for males and ≥ 470 msec for females at screening.
•History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
•Pregnant, Women of child-bearing potential or breastfeeding women.
•Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
•History (within 5 years prior to study start) of clinically significant gastritis, pyloric channel stenosis, peptic ulcer or duodenal ulceration, gastro-esophageal reflux, gastrointestinal bleeding, rectal bleeding or other clinically significant GI abnormalities.
•History (within 5 years prior to study start) of orthostatic hypotension, cardiovascular disease, stroke, transient ischemic attack, fainting or blackouts.
•Clinically relevant chronic or acute infectious illnesses or febrile infections within 2 weeks prior to start of the study.
•Newly occurred (within 2 weeks of screening visit) cutaneous and mucosal alterations.
+10 more criteria

Locations (1)

GSK Investigational Site

Erfurt, Thuringia, Germany

Key Dates

Start Date

February 22, 2016

Primary Completion Date

April 13, 2016

Completion Date

April 13, 2016

Last Updated

January 24, 2019

Enrollment

ACTUAL participants

Conditions

Infections, Respiratory Tract

Interventions

Fluimucil® 2% solution

DRUG

Acetylcysteine 2% solution

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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