Health TrialsbyHealthPanel

Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Minnesota

About this trial

LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult healthy male or female

Age 18 to 65 years

Willingness and ability to complete study procedures

Disqualifiers

medical conditions that require taking medications regularly.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Formulation A

    Drug

    outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD

  • Formulation B

    Drug

    outer sachet 150mg CD/0mg LD and inner sachet 600mg LD

  • Formulation C

    Drug

    outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Formulation AActive comparator 1 intervention
Group B: Formulation BActive comparator 1 intervention
Group C: Formulation CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood CD Level - Minute 15

Measured in \[ng/mL\]

Time frame
Minute 15 after administration
2

Blood LD Level - Minute 15

Measured in \[ng/mL\]

Time frame
Minute 15 after administration
3

Blood CD Level - Minute 30

Measured in \[ng/mL\]

Time frame
Minute 30 after administration
4

Blood LD Level - Minute 30

Measured in \[ng/mL\]

Time frame
Minute 30 after administration

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: