NCT01571921

Gamma-delta Tocotrienol as Potential Maintenance Treatment in Women With Metastatic Breast Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Malaysia Palm Oil Board · Other Government
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction	Single oral TRF or Gamma-Delta Tocotrienol dosage

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2012-04-05
• Last updated: 2016-09-14

Locations

1 site across 1 country: Malaysia