Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Condition: Healthy
Intervention: Diclofenac sodium; Diclofenac sodium and safinamide
Intervention description: Diclofenac sodium 50 mg single dose; Diclofenac 50 mg single dose and safinamide 200 mg single dose
Intervention MeSH terms: Diclofenac
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 22 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK study

Summary:

      To evaluate if a single dose of safinamide 200 mg has an effect on the pharmacokinetics of
      diclofenamic acid, concomitantly administered as a single 50 mg diclofenac sodium dose, with
      respect to 50 mg diclofenac sodium administered alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed written informed consent before inclusion in the study

          2. Males and females, 25-55 years old

          3. Body Mass Index (BMI): 18.5-30 kg/m2

          4. Systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate
             50-90 bpm

          5. Ability to comprehend the full nature and purpose of the study

          6. Females of child-bearing potential must use at least one of the following :

        A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge
        with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2
        months before the screening visit A male sexual partner who agreed to use a male condom
        with spermicide A sterile sexual partner Female participants of non-child-bearing potential
        or in post-menopausal status for at least 1 year were admitted.

        Exclusion Criteria:

          1. Contraindications to MAO-B inhibitors, antiepileptic drugs, or to any NSAIDs

          2. Clinically significant abnormalities in ECG

          3. Clinically significant abnormal physical findings

          4. Clinically significant abnormal laboratory values

          5. Hypersensitivity or history of anaphylaxis to drugs or allergic reactions in general

          6. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory,
             skin, haematological, endocrine or neurological diseases

          7. Medications, including over the counter medications and herbal remedies, NSAID or
             anticoagulant use for 2 weeks before and during the entire study; morphine or other
             similar opioids, SSRIs, SNRIs, tri- or tetracyclic antidepressant, tramadol,
             pethidine, dextromethorphan, MAO inhibitors, meperidine derivatives and antiepileptic
             drugs, medicinal products that are BCRP substrates, any known enzyme inhibiting or
             inducing agent within 4 weeks preceding the screening visit.

          8. Participation in the evaluation of any investigational product for 3 months before the
             study.

          9. Blood donations for 3 months before the study

         10. History of drug, alcohol, caffeine or tobacco abuse

         11. Positive drug test at screening or day -1

         12. Positive alcohol breath test at day -1

         13. Abnormal diets or substantial changes in eating habits in the 4 weeks before the
             study; vegetarians

         14. Positive or missing pregnancy test at screening or day -1, pregnant or lactating women