The aim of this research is to determine the surface area of an oil depot during oil clearance. This is relevant for the release rate and therefore for the absorbed amount of active substance in blood. The volume is important for the interstitial…
ID
Source
Brief title
Condition
- Administration site reactions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the determination of the surface (mm2) and the
volume of the depot (mm3). During the study, the surface area and volume will
decline, which is relevant to the release of the active substances in
registered oil depots.
Secondary outcome
not applicable
Background summary
Controlled and sustained drug release and drug compliance are the major
benefits of parenteral oil depot formulations. However, nowadays it is not
possible to predict blood plasma concentrations, because there is no data for
modeling available about release kinetics out of oil depots.
Formulation is still a matter of trial and error requiring a lot of extra in
vivo studies. Therefore, to reduce this burden of experiments, there is a need
for a scientific basis which would enable the formulation to design rather than
to empirically find the suitable formulation.
Study objective
The aim of this research is to determine the surface area of an oil depot
during oil clearance. This is relevant for the release rate and therefore for
the absorbed amount of active substance in blood. The volume is important for
the interstitial pressure in the muscle which plays a role in the uptake via
the lymph. Furthermore, with this knowledge we can predict the release rate for
all substances in oil depots by modeling.
Second, rate of oil clearance can be determined. This is relevant for multiple
injections at the same injection place in multi dose therapy.
Study design
Proof of Principle / Observational study with invasive intervention
Intervention
Two placebo injections will be injected: one in the deltoid muscle and one in
the vastus lateralis muscle of the volunteer. This is a sterile injection
preparation. The injection volume is 1.0 mL.
Study burden and risks
The risks for volunteers to participate in our study are negligible. Extent of
burden: one injection of an oil depot and eight MRI-scans. Because all
volunteers are co-workers of the UMC Utrecht, no extra site visits are
necessary.
The oil depot is an existing formulation with no active substances, so the
injection is safe. MRI-scans are also safe and the scans are approved by
Division Medical Imaging (UMC Utrecht).
There are no physical examinations, questionnaires or other tests that involve
risks and burdens.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- male;
- age between 18 and 65 years;
- the patient is willing to give informed consent for participating in the study
Exclusion criteria
- female;
- depots in the upper arm is present at the time of inclusion;
- allergies to sesame oil and / or benzyl alcohol;
- medication that contribute to the clearance of oil;
- smoking
- claustrophobic
- pacemaker
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50387.041.14 |