Phase 1a: A Randomized, 2-period Cross-over Study to Compare the Bioavailability of Gamma-Delta Tocotrienol (GDT) With That of Tocotrienol Rich Fraction (TRF) in Twelve Healthy Subjects
21 Years
55 Years
Both
Healthy Subjects
Trial Information
Phase 1a: A Randomized, 2-period Cross-over Study to Compare the Bioavailability of Gamma-Delta Tocotrienol (GDT) With That of Tocotrienol Rich Fraction (TRF) in Twelve Healthy Subjects
Twelve healthy subjects will be admitted to a clinical study ward on the Day 0. Physical
check up and the health status will be confirmed during check in. After fasting for a
minimum of 10 hours overnight, each subject will be administered a single dose of TRF or
Gamma-Delta after taking a standardized high-fat meal breakfast on Day 1. Thereafter,
standard meals will be provided at 4 and 12 hours after dosing. Blood samples (5mL will be
taken using an in-dwelling canula placed in the antecubital vein immediately before and at
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, and 24 hours after dosing. Subjects will be admitted
for 24 hours and discharged after the last blood sampling. During the study, blood pressure
and the heart rate will be monitored regularly for safety profile.
After a one week wash out period, subject will return to the ward and be given the other
formulation (TRF or GDT) and the same procedures will be repeated. Any adverse events that
arise during the treatment will be recorded and followed up till resolution.
Inclusion Criteria:
- Male and female aged 21-55 years old
- Good health
- No allergy to vitamin E/ palm oil
- No past (within 3 months) / current use of dietary supplements containing vitamin E
Exclusion Criteria:
- History of bleeding tendencies or any condition predisposing to bleeding e.g.
thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis),
gastrointestinal ulcers
- Candidate for surgery or had undergone surgery in the past 6 months
- Current or past use (last 3 months) of antithrombotic drugs such as antiplatelets
(aspirin, ticlopidine), anticoagulants (heparin, warfarin), thrombolytic agents
(streptokinase), etc
- Current or past history of cancer
- Pregnant/ breastfeeding women
- Smokers
- Drug or alcohol abuse
- Hypercholesterolemia
- Chronic conditions such as uncontrolled hypertension, heart disease (ischemic heart
disease, heart failure, cardiac arrhythmia), uncontrolled diabetes, HIV infection, or
other psychiatric illness/ social situations that might limit adherence to study
protocol.
- Unable or unwilling to stop taking vitamins, herbal preparations or nonprescription
medications
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Peak Plasma Concentration (Cmax)of drug
Outcome Time Frame:
0 to 24 hours after dosing
Safety Issue:
No
Principal Investigator
Nur Aishah Mohd Taib
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Malaya Medical Centre
Authority:
Malaysia: Ministry of Health
Study ID:
896.128
NCT ID:
NCT01571921
Start Date:
July 2012
Completion Date:
October 2012
Related Keywords:
- Healthy Subjects
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