A Pharmacokinetic Study of Nutri-PEITC Jelly in Head and Neck Cancer Survivors

NCT03700983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-10-09

No results posted yet for this study

Summary

This research aims to evaluate the absorption and elimination profile of a bioactive compound PEITC in the matrix of Nutri-jelly - a novel edible nutritious gel. Thus, the investigators conducted a pharmacokinetic study in 12 head and neck cancer survivors. After consumed a serving of Nutri-jelly containing 20 mg PEITC, plasma levels of PEITC at 0, 1, 2, 3, 4, 6, 8, 12 and 24 hours were specifically measured by ammonia derivatization and analyzed by liquid chromatography-mass spectrometry (LC-MS/MS). Non-compartmental pharmacokinetic analysis was performed.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nutri-PEITC jelly

an edible, easily to swallow nutritious gel containing a bioactive compound PEITC

Sponsors & Collaborators

  • Maha Vajiralongkorn Thanyaburi Hospital

    collaborator UNKNOWN
  • Mahidol University

    collaborator OTHER
  • Srinakharinwirot University

    collaborator OTHER
  • Dental Innovation Foundation Under Royal Patronage

    lead OTHER

Principal Investigators

  • Dunyaporn Trachootham, DDS, PhD · Mahidol University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-06
Primary Completion
2018-07-01
Completion
2018-09-30

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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 NCT03700983 on ClinicalTrials.gov