Study 1

The first study was a so-called bioequivalence study, where the aim was to compare Sensidose’s own product, Flexilev® microtablets, with the same total dose of an existing drug product. This is a procedure that is common in the registration of generic drugs.

The aim of a bioequivalence study is to show that there is no significant difference in terms of absorption, distribution, metabolism or excretion of the active substance, what is also called pharmacokinetics. The drugs are given as single doses on one occasion, usually to healthy volunteers, under standardized conditions.

At predetermined points in time blood samples are drawn for analysis. In order for the substances to be considered bioequivalent, the rate of uptake as well as the degree of drug absorption and metabolism must be the same. If the tested product is bioequivalent with an already registered product, you can in principly apply for marketing approval of the new product.

Read more »

Study 2

The rapid metabolism of levodopa is a problem for patients with Parkinson’s disease. In order to function normally they need to have a constant and individually adjusted plasma level of the drug. In this way a steady synthesis and availability of dopamine in the brain, with stable motor and psychomotor function is achieved. The drug Stalevo® contains levodopa and carbidopa, but also an inhibitor of the COMT enzyme and is considered to be the preparation in tablet form that best enables the desired steady supply of levodopa.

In a recently completed clinical study Flexilev was compared with Stalevo®. The study was a multiple dose, open, randomized, two-way crossover, phase I study in healthy volunteers.

Read more »

Study 3

A recurring question is whether the results we obtained in healthy volunteers (see study 1) are applicable to patients with Parkinson’s disease in a more advanced phase. This study was conducted to answer this question. The study had two main objectives: 1) to investigate the pharmacokinetics (absorption, distribution, metabolism or excretion) of Flexilev in patients and 2) to monitor the effect of the dose by repeated examinations of motion with different measurement methods.

The study was a single dose, open, phase I study and was conducted at Uppsala University Hospital. 19 patients who had a average of 9.5 years duration of Parkinson’s disease participated in the study.

Read more »

Study 4

Flexilev contains the same active ingredients as similar approved medicines. The difference is that treatment with Flexilev is individualized, ie the dose is adjusted according to each individual’s needs in steps of 5 mg. This accuracy in dosage can only be obtained with Flexilev. But is it effective? In this study, personalized treatment with Flexilev minitablets was compared to standard treatment.

The study was a four week open observational study conducted at the Sahlgrenska Hospital in Gothenburg. 24 patients participated and, on average, they had their Parkinson’s diagnosis for 9.5 years. To be able to participate in the study, the requirement was to take levodopa at least four times a day and have remaining symptoms. The study period was divided into two two-week periods. During the first, the participants received the same medication as before but given with Flexilev minitablets and the MyFID dosing device. However, the treatment itself was identical to that the patient had before the study. In the second two-week period, the dose was adjusted according to patient needs and in line with a motion measurement. Participants underwent the same type of tests before the study and after each of the two two-week intervals with different treatment.

Read more »