Clinical studies
Studies conducted according to the rules – just more quickly
Even quite a simple study can take two years or more to progress from concept to initial results. SWIPP constant aim is to reduce the length of this process as much as possible – without compromising neither the quality of the studies nor the safety of the study participants.
However, clinical studies always require extensive preparations. This also applies to short-term studies involving healthy trial volunteers. The purpose and design of the study must be determined, a detailed study protocol must be produced, together with a detailed description of the investigational product that will be used. A number of authorisations are required: authorisation to conduct a clinical trial from the relevant medicines agency, approved application for ethical approval, as well as import and export licences for products containing narcotic substances, which was the case for our midazolam studies. Finally, a GMP batch of the actual investigational product must be manufactured and the comparator product must be procured and imported.
An additional challenge is that numerous different parties are involved, in addition to the sponsor (i.e. SWIPP). Contract clinics (CROs), GMP manufacturers, transport companies, monitors, pharmacovigilance, and so on, which all requires coordination and smooth cooperation.
- SWIPP has so far sponsored three studies
- SWIPP-010, with EudraCT no. 2020-004912-82 and the title “Randomized, open-label, single dose, three-period, comparative bioavailability study of SWIPP Midazolam buccal film 10 mg (Test), versus XXXX (Reference) in healthy adult male subjects under fasting conditions”. Plasma concentrations of midazolam over time in the subjects were determined. The study was part of Project 1 and took place in Jan-Feb 2021. The results were deemed to be a great success by SWIPP’s management and Board.
- SWIPP-012, with EudraCT no. 2021-003587-27 and the title “Randomized, open-label, single dose, two-period, comparative bioavailability study of SWIPP Midazolam buccal film 10 mg (Test), versus XXXX (Reference) in healthy adult male subjects under fasting conditions”. Plasma concentrations of midazolam and the metabolite 1-OH-midazolam over time in the subjects were determined, and the pharmacodynamic effect was also studied with the aid of the Ramsay Sedation Scale. The study was part of Project 1 and took place from Dec 2021 to Jan 2022. The results were deemed to be a great success by SWIPP’s management and Board.
- SWIPP-011, with EudraCT no. 2021-003692-33 and the title “Randomized, open-label, single dose, four-period, four-treatment, cross-over, comparative bioavailability study of SWIPP midazolam film 5 mg and 10 mg and XXXX and XXXX in healthy adult male subjects under fasting conditions”. Plasma concentrations of midazolam and the metabolite 1-OH-midazolam over time in the subjects were determined, and the pharmacodynamic effect was also studied by the Ramsay Sedation Scale. The study was part of Project 2 and took place in Feb-March 2022. The results were deemed to be a great success by SWIPP’s management and Board.
XXXX represents the name of the comparator product, which SWIPP prefers not to disclose here.
When preparations begin for the next clinical study, information will be made available on this website
SWIPP’s products must be safe to use
All the studies conducted so far have been deemed both conclusive and successful. They have enabled each project to progress to the next stage and have also increased SWIPP’s general insights regarding the bioavailability of midazolam. An equally important outcome has been that the studies have supported the assumption that SWIPP’s products are safe to use. A total of about 100 doses of SWIPP’s films have been administered to a total of about 60 trial subjects. None of the infrequent and mild adverse events (AE) that were observed during the studies were deemed to have been caused by SWIPP’s film.

