Clinical Trials Logo

Clinical Trial Summary

It is the aim of the study to investigate the functioning of a drug delivery system (drug-rich particles forming hot-melt extruded amorphous solid dispersions) with respect to mechanisms of bioavailability of poorly soluble drug substances.


Clinical Trial Description

Poor drug solubility, and therefore low bioavailability, remains a problem in drug development that causes many drug candidates to drop out during drug development. Bioavailability is linked to drug solubility and intestinal permeability. A promising method to increase drug solubility, and therefore bioavailability, is the formulation of the drug as hot-melt extruded amorphous solid dispersion drug delivery systems, which have been shown to potentially increase in vivo and clinical bioavailability.The mechanisms that lead to increased bioavailability are not understood completely. In this study, investigators investigate the role of amorphous solid dispersions and thereof generated drug-rich particles on bioavailability and their in vivo behaviour. Investigators do so by administering the delivery system at different stages in the process of drug availability. Primary objectives are the pharmacokinetic analysis of a model formulation using efavirenz as model drug tracer in human. - Comparison of pharmacokinetic parameters such as relative bioavailability and further parameters derived from pharmacokinetic analysis and corresponding interpatient variabilities. - Mechanistic analysis of pharmacokinetic data, such as determination of in vivo dissolution from the solid formulation (study product 1) to drug rich particles (study product 2) using numerical deconvolution or analysis of the effect of drug rich particles on the absorption rate of Efavirenz in comparison to the solution of Efavirenz (study product 3). Secondary objectives are the comparison of obtained pharmacokinetic profiles to existing data of a conventional formulation with respect to: - Comparison of pharmacokinetic parameters such as relative bioavailability and further parameters derived from pharmacokinetic analysis and corresponding interpatient variabilities. - Extrapolation investigation from in vitro to in vivo data. Safety objectives are the recording of any side effects or tolerability issues of the investigational drug delivery system. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03886766
Study type Interventional
Source University Hospital, Basel, Switzerland
Contact
Status Completed
Phase N/A
Start date April 30, 2019
Completion date March 19, 2020

See also
  Status Clinical Trial Phase
Completed NCT05544786 - Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants. Phase 1
Completed NCT04744233 - Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects. N/A
Completed NCT05561075 - Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form (BIOPTERO) N/A
Completed NCT03873909 - Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit N/A
Completed NCT03353857 - Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam Phase 1
Completed NCT05121506 - A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults Phase 1
Completed NCT01267201 - A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form Phase 1
Completed NCT02538393 - Relative Bioavailability of Sorafenib Tablet for Oral Suspension Phase 1
Completed NCT05116982 - Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL) N/A
Completed NCT04207372 - Protein Digestibility of Whey and Zein. N/A
Completed NCT01853800 - Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet Phase 1
Completed NCT00714584 - Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers Phase 1
Completed NCT04876261 - Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements N/A
Completed NCT03886597 - Nutritional Intervention With Table Olives in Healthy Volunteers Phase 1/Phase 2
Completed NCT06289140 - Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2) N/A
Completed NCT05439408 - Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions Phase 1
Completed NCT03951025 - Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN) Phase 2
Completed NCT03984916 - Study of the Bioavailability of Three Hesperidin Extracts. N/A
Completed NCT02966704 - Stable Isotope Method to Assess Dietary Protein Quality N/A
Completed NCT02847117 - Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults. N/A