A new formulation of Gamma Delta Tocotrienol has superior bioavailability compared to existing Tocotrienol-Rich Fraction in healthy human subjects.
Gamma and delta tocotrienols are isomers of Vitamin E with established potency in pre-clinical anti-cancer research. This single-dose, randomized, crossover study aimed to compare the safety and bioavailability of a new formulation of Gamma Delta Tocotrienol (GDT) in comparison with the existing Tocotrienol-rich Fraction (TRF) in terms of gamma and delta isomers in healthy volunteers. Subjects were given either two 300 mg GDT (450 mg γ-T3 and 150 mg δ-T3) capsules or four 200 mg TRF (451.2 mg γ-T3 &102.72 mg δ-T3) capsules and blood samples were taken at several time points over 24 hours. Plasma tocotrienol concentrations were determined using HPLC method. The 90% CI for gamma and delta tocotrienols for the ratio of log-transformation of GDT/TRF for Cmax and AUC0-∞ (values were anti-logged and expressed as a percentage) were beyond the bioequivalence limits (106.21-195.46, 154.11-195.93 and 52.35-99.66, 74.82-89.44 respectively). The Wilcoxon Signed Rank Test for Tmax did not show any significant difference between GDT and TRF for both isomers (p > 0.05). No adverse events were reported during the entire period of study. GDT was found not bioequivalent to TRF, in terms of AUC and Cmax. Gamma tocotrienol in GDT showed superior bioavailability whilst delta tocotrienol showed less bioavailability compared to TRF.
Department of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.|Department of Pharmacology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.|Malaysian Palm Oil Board (MPOB), No. 6 Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor, Malaysia.
Puvaneswari
P
Meganathan
Department of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Rafid Salim
RS
Jabir
Oncology Clinical Unit, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Ho Gwo
HG
Fuang
Department of Social and Preventive Medicine (SPM), Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Nirmala
N
Bhoo-Pathy
Clinical Investigation Centre, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Roma Basu
RB
Choudhury
Department of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Nur Aishah
NA
Taib
Malaysian Palm Oil Board (MPOB), No. 6 Persiaran Institusi, Bandar Baru Bangi, 43000 Kajang, Selangor, Malaysia.
Kalanithi
K
Nesaretnam
Department of Pharmacology, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.
Zamri
Z
Chik
D000328:Adult; D000704:Analysis of Variance; D019540:Area Under Curve; D001682:Biological Availability; D002839:Chromans / Q000008:administration & dosage* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004339:Drug Compounding; D005260:Female; D006207:Half-Life; D064368:Healthy Volunteers; D006801:Humans; D007536:Isomerism; D008297:Male; D012372:ROC Curve; D024508:Tocotrienols / Q000097:blood; D014810:Vitamin E / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D055815:Young Adult
D002839:Chromans; D024508:Tocotrienols; D014810:Vitamin E; C082097:tocotrienol, delta; C013649:plastochromanol 8