NCT02462746|CompletedPhase 1DMC
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Sponsor study identifier
interventional
24
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)The purpose of this project is to study the effect of dietary supplementation with a natural health product (NHP) with a focus on its effects on its levels in breast milk.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 2, 2015
Actual (reported)June 4, 2015
Actual (reported)April 2016
Actual (reported)April 2016
Actual (reported)Breast milk cysteine levels
measurement of amino acid before and after acute administration over a 10 hour period * The first visit would be the screening visit, which the subjects will be evaluated for general health status through a standardized health questionnaire. A urine test will be done in order to screen for any drug use. * On the second visit, each subject would be tested for plasma levels of the amino acid during the day. In addition breast milk will be tested in order to examine the effect of these supplements on the amino acid contents of the breast milk at few time points on both days.
The main protocol occurs of 10 hours of time when the pharmacokinetics of the amino acid are measured.
plasma cysteine levels
These are sampled over 10 hours before and after administration of cysteine
This group subjects will not receive the supplement
Intervention: single dose of 1.5 g L-Cysteine.
Intervention: single dose of 3.0 g L-Cysteine.
The trade name is New Root Herbal Inc.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Research Imaging Centre, Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8, Canada
Jeff Meyer, MD,PhD
Centre for Addiction and Mental Health, Research Imaging Centre, Toronto, Ontario, Canada M5T 1R8
24 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2015
First Posted
June 4, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
Contact the study team to confirm eligibility.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
September 8, 2016
Record last verified: 2016-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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