Home » Trials » SLCTR/2016/001


A study to determine the palatability of different dosage forms of oral N-Acetylcysteine and methionine among healthy volunteers

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SLCTR Registration Number

SLCTR/2016/001


Date of Registration

19 Jan 2016

The date of last modification

Jan 29, 2019


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

A study to determine the palatability of different dosage forms of oral N-Acetylcysteine and methionine among healthy volunteers


Public Title of Trial

A study to determine the palatability of different dosage forms of oral N-Acetylcysteine and methionine among healthy volunteers


Disease or Health Condition(s) Studied

Palatability of antidotes to paracetamol poisoning


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

ERC Peradeniya 2014/EC/95


Trial Details


What is the research question being addressed?

What is the difference in palatability of different dosage forms of N-acetylcysteine and methionine among healthy volunteers?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Crossover


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

The study will be carried out at the South Asian Toxicology Research collaboration, Faculty of Medicine, University of Peradeniya. Undergraduates of the University of Peradeniya who are not enrolled in the medical faculty (i.e. non-medical students) will be invited to participate. Each participant will be randomized to follow the identified sequences in receiving each intervention.

Interventions
1. Single therapeutic dose of oral Nā€“ acetylcysteine (NAC) tablets (70mg/kg *50kg = 3500mg)
2. Single therapeutic dose of oral Nā€“ acetylcysteine (NAC) capsules (70mg/kg *50kg = 3500mg)
3. Single therapeutic dose of oral methionine tablets (2500mg)
4. Single therapeutic dose of oral methionine capsules (2500mg)
5. Single dose of folic acid (400 mcg)

Each participant will receive each of the five interventions in the sequence determined at randomization. A washout period of 1 week take place between each intervention.


Inclusion criteria

  1. Healthy male and female volunteers (who are not medical students)
  2. Age 19-26 years

Exclusion criteria

  1. Condition or dietary habit known to interfere with the sense of smell and taste
  2. Ingestion of any other medication within 48 hours
  3. Significant illness within the previous two weeks
  4. History of autonomic dysfunction
  5. Atopic allergy
  6. Known hypersensitivity to any drug
  7. Pregnancy or breast feeding


Primary outcome(s)

  1. Each of the following outcomes will be scored on a modified 100 mm visual analogue scale.
    1.1.Smell 1.2.Taste 1.3.Ease of swallowing
    1.4. After taste 1.5. Adverse events within one hour

    [

    Just after the administration up to one hour

    ]

Secondary outcome(s)

  1. None

    [

    None

    ]

Target number/sample size

30


Countries of recruitment

Sri Lanka


Anticipated start date

2016-01-24


Anticipated end date

2016-03-31


Date of first enrollment

2016-04-21


Date of study completion


Recruitment status

Complete: follow up complete


Funding source

South Asian Clinical Toxicology Research Collaboration


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2015-06-11


Approval number

2014/EC/95


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address: Galaha Road, Kandy, Sri Lanka
Telephone: +94-812396361
Email: chairpersonierc@gmail.com


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Indika Gawarammana
Professor in Medicine
SACTRC, Faculty of Medicine University of Peradeniya Peradeniya
0814479822
0714225081
0814479822
indikagaw@gmail.com

Contact Person for Public Queries

Ms. Vindya Pathiraja
Postgraduate Researcher
SACTRC, Faculty of Medicine University of Peradeniya Peradeniya
0814479822
0713774520
0814479822
vindyamytime@gmail.com


Primary study sponsor/organization

South Asian Clinical Toxicology Research Collaboration
None
SACTRC, Faculty of Medicine University of Peradeniya
0814479822
0814479822
enquiry@sactrc.org
www.sactrc.org

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results