TA-65 Pharmacokinetic Study

This is an open labeled, replicate cross-over study with eight (8) subjects which will include men and women (non childbearing age) and be completed over a period of six (6) weeks. The supplement TA-65 will be given to subjects in both capsules and powder form. TA-65 is a dietary supplement. The active ingredient is isolated from roots of Astragalus species. The active ingredient has been proven to activate an enzyme called telomerase. TA-65 in intended to supplement the diet to increase the general health through telomerase activation. The active ingredient has poor oral bioavailability in humans. The current study is aimed at assessing the bioavailability of the active ingredient with different formulations designed to enhance the bioavailability. The objective of the study is to determine the steady state pharmacokinetic profile of TA-65 following oral dose of formulated (powder and capsules) and unformulated (powder) forms as assessed by Cmax, Tmax and AUC (area under the curve). This will be a pilot, open-label, replicate cross-over study to evaluate the pharmacokinetic profile of active ingredient in eight subjects following the oral intake of TA-65 varying in formulations and doses. The subjects are expected to participate in this study for a period of 28 days. After initial screening, all subjects will visit the study center on five different days (day 1, day 7, day 14, day 21 and day 28). During each visit, all eight subjects will orally take one of the five test materials. The washout period is seven days during which all subjects refrain from taking TA-65 in any form. Pharmacokinetic sampling for measurement of plasma concentrations will be conducted over a 12 hour period following the oral dose. Blood will be withdrawn from all subjects prior to the intake of the test materials (0 hr.) and 1, 2, 3, 4, 5, 7, 10 and 12 hours following the oral intake of the test material. Serum will be separated from each blood sample and stored at -20° C. The amount of TA-65 in each serum samples will be analyzed by mass spectrometry.