Pharmacokinetics and bio-distribution of PLGA nano-partials of rifampicin in healthy human volunteers.
A prospective, open-label, non-randomized, single-dose study, approved by our Institutional Ethics Committee (IEC) and Institutional Bio-Safety Committee (IBSC). Registered in the Clinical Trials Registry-India (CTRI/2022/02/040372). This study was conducted to characterize the bio-distribution and pharmacokinetics of a single oral dose of radiolabeled PLGA nanoparticles loaded with rifampicin, containing approximately 5-10 mCi of radioactive material, administered to normal healthy volunteers. Urine and blood were collected, and images were acquired to study pharmacokinetics (PK) and biodistribution till the end of the study.