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NCT05471609 | RECRUITING | Healthy Volunteers


Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Sponsor:

University of Minnesota

Brief Summary:

Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.

Condition or disease

Healthy Volunteers

Intervention/treatment

levodopa/carbidopa oral formulation A

levodopa/carbidopa oral formulation B

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : DOUBLE
Masking Description : Double-blinded
Primary Purpose : TREATMENT
Official Title : Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Actual Study Start Date : 2025-06-12
Estimated Primary Completion Date : 2026-06-16
Estimated Study Completion Date : 2026-06-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Normal healthy
  • * Are 18-65 years of age
  • * Are not currently taking medications regularly
  • * Able to fast 6 hours (water allowed)
Exclusion Criteria
  • * Pregnancy
  • * Inability to fast

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Location Details

NCT05471609


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Locations


RECRUITING

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

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