This is an open-label, randomized, multiple-dose, three-period crossover study in healthy male and female volunteers to characterize pharmacokinetics and assess the relative bioavailability of two new oral formulations of the investigational drug - prolonged-release hard capsules and effervescent tablets compared to the previous drug formulation – tablets.
The aim of this clinical trial is to study pharmacokinetics and investigate relative bioavailability of prolonged-release hard capsules and effervescent tablets in comparison to tablets.
The study will be conducted in healthy male and female volunteers, in one clinical trial centre in The Russian Federation.
The study will be exploratory in its nature. Based on regulatory requirements on bioavailability/bioequivalence studies in the Russian Federation, the minimal anticipated number of subjects is at least 18. Accounting for up to 6 dropouts, 24 subjects will be included in this study.
OCT works with a number of phase I units in countries of our operation. For this study, we have selected a phase I unit that was able to enroll the required number of patients in less than 4 months, thus having met the planned rate.
Different oral formulations of the investigational drug are marketed worldwide. However, only few immediate release formulations of the IMP have been authorized to date in the Russian Federation: tablets, solution for oral use, syrup, and soft pastilles. New oral formulations of are available now for authorization in Russian Federation: immediate-released formulation as effervescent tablet 60 mg and prolonged release formulation as prolonged-release hard capsule.
The described comparative study on pharmacokinetics and bioavailability should be conducted with test formulations in order to allow interchangeability of safety and efficacy data between different formulations.
The Sponsor of this clinical trial has already conducted several bioequivalence (BE) studies of the above described drugs: one clinical study on steady state pharmacokinetics of prolonged release hard capsules, conducted previously in Germany, demonstrated bioequivalence
of the prolonged-release hard capsule formulation to tablet formulation with respect to the extent of absorption. However, the bioavailability of the effervescent tablets has not been evaluated in that clinical study.
A number of bioavailability and bioequivalence studies on other oral formulations of
The investigational drug (syrup, oral solution, film-coated tablets, and granules) showed bioequivalence of the new formulations to regular tablets e.g. on rate and extent of absorption.
Furthermore, based on the high solubility and high permeability of the investigational drug, it could be considered as a BCS (Biopharmaceutics Classification System) class 1 drug.
Hence, although not tested within one trial, various immediate formulations can be expected to result in a comparable bioavailability.
OCT has conducted more than 30 BE and phase I studies in healthy volunteers since 2005 and we are doing our best to deliver high quality services to each of our clients.