View clinical trials related to Bioavailability.
Filter by:This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers. The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.
Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus oral tablet formulation and effect of food on the mini-tablet formulation.
This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15 subjects who will receive single oral doses of investigational medicinal product (IMP) across 3 treatment periods.
In vitro studies found supplemental levels of iron and zinc to inhibit the micellization and cellular uptake of β-carotene. Here, we investigated this in vivo, in a double-blind 3-arm crossover human trial. Healthy males (n=6) ingested, with breakfast, a single dose of 15 mg β-carotene in combination with either a placebo, 25 mg iron or 30 mg zinc capsule. Blood samples were collected at baseline and hourly for 10 hours. The triacylglycerol-rich fraction (TRF) was analysed for concentrations of β-carotene and plasma for β-carotene, retinol, triacylglycerols, LDL- and HDL-cholesterol.
Results from several clinical studies show that orally administered melatonin has low bioavailability and a very short half-life. Phenyl capsaicin, a synthetic analogue of capsaicin, might increase its bioavailability by inhibiting the enzymes involved in its hepatic metabolism. Thus, the hypothesis of the present study is that the administration of melatonin supplement with phenyl capsaicin presents greater bioavailability than a melatonin supplement that does not contain phenyl capsaicin.
In the current study, the OAT fibril - Fe SA (Fe-oat 1) and OAT fibril - Fe NaOH (Fe-oat 2) will both be studied in vivo, alone are oat fibril powder add iron supplement is soluble in water and oat fibril powder add iron supplement is soluble in water in a food matrix (acai puree and honey) to assess their promise as Fe food fortificants. This first in human study to bioavailability assessment and adverse effect of the OAT fibril - Fe SA (Fe-oat 1), OAT fibril - Fe NaOH (Fe-oat 2) and in a food matrix to assess their promise as Fe food fortificants. This study will be conducted with the following objectives. 1. To conduct a stable Fe isotope study to evaluate the bioavailability of OAT-Fe formulated using two reducing agents (Fe-oat 1 and Fe-oat-2) and compared to FeSO4. 2. To compare the performance of Fe-oat 1 and 2 in a food matrix containing Fe inhibitors, (acai puree and honey) in comparison to FeSO4 in a similar meal matrix.
The objective of this study is to assess the relative bioavailability of select nutrients from two formulations of a multivitamin/mineral supplement in healthy adults.
The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.
This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.
The oral bioavailability of Oleanolic acid (OA) when formulated as functional olive oil, and its mechanisms of systemic transport, will be approached by mean of randomized and controlled trial with 20 healthy volunteers. Ten individuals randomly selected will receive 55 mL of the functional OA-enriched olive oil (equivalent dose 30 mg OA) as part of an experimental breakfast. The other ten participants will receive within this experimental meal the same amount of the control olive oil. Immediately before and after eating the respective breakfasts, aliquots of cubital blood will be drawn every hour, over a postprandial period of 7 hours. Since in this trial design, each participant is his/her own control, a four-week washout period is established, after which a new series of tests that cross the type of olive oil consumed will be carried out. From the aliquots of cubital blood, sera will be obtained by centrifugation. The extraction and quantification of serum OA will be realized by gas chromatography (GC) using flame ionization (FID) and mass spectrometry (MS) detectors. In the pharmacokinetic analysis of data, a mono-compartmental model will be assumed. It will be determined: 1) absorption parameters such as the maximum concentration achieved and the timing for it, the constant of absorption and the area under the curve; 2) distribution parameters such as the constant and volume of distribution; 3) metabolism parameters, such as the OA fraction associated with albumin; and 4) elimination parameters such as the elimination constant, the half-life and the clearance. To demonstrate the presence of OA in postprandial TRL, chylomicron and VLDL fractions will be prepared by plasma ultrafiltration in normal saline, and hydrolysed with pancreatic enzyme. The possible presence of OA among the TRL-derived lipids will be evaluated. The content of apo B48 and B100, as markers of the presence of chylomicrons and VLDL, respectively, will be determined by ELISA. Other parameters related to glycemic control, such as serum insulin, C-peptide and GLP-1 will be analyzed by ELISA.