Healthy Subjects Clinical Trial
Official title:
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 volunteers who fit the inclusion and exclusion criteria and provide written informed consent to participate in the trial will be recruited to compare the rate and extent of absorption and pharmacokinetics of the newly formulated Gamma-Delta formulation with TRF.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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