Clinical TrialID 8276
A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA®
NCT06037590
Parkinson|Parkinson Disease|Parkinson's Disease and Parkinsonism
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 8276
- Evidence Id
- 8276
- Core Evidence Id
- 8276
- Source Clinical Trial Id
- 8274
- Herb2 Clinical Trial Id
- HBCT008274
- Nct Id
- NCT06037590
- Title
- A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA®
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Parkinson|Parkinson Disease|Parkinson's Disease and Parkinsonism
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- COMBINATION_PRODUCT: Levodopa Cyclops™|COMBINATION_PRODUCT: INBRIJA®
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 26
- Outcome Measure
- The dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops™ versus Inbrija®, The primary objective of the present trial is to determine the dose at which comparative bioavailability of levodopa will be reached between Levodopa Cyclops™ versus Inbrija® in healthy adult subjects after an oral inhalation of a single dose of 45, 90 and 135 mg levodopa under fasting conditions administered with 50 mg carbidopa one hour prior IMP administration in 3 study periods and after a single dose of 66 mg levodopa delivered dose (2 hard capsules containing 42 mg levodopa each) of Inbrija® administered with carbidopa 50 mg one hour prior to IMP administration in a fourth study period., 5 days
- Sponsor Collaborator
- PureIMS B.V.|Cooperative Clinical Drug Research and Development AG (CCDRD AG)
- Funded By
- INDUSTRY
- Location
- Bed space for short term stay at Diagnostic & Consultative Centre 'Ascendent' Ltd., Sofia, 1202, Bulgaria
- Other Id
- 2023-504687-42-00
- Start Date
- 2023-09-25
- Primary Completion Date
- 2023-10-20
- Completion Date
- 2023-10-27
- First Posted
- 2023-09-14
- Results First Posted
- Last Update Posted
- 2023-10-27
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT06037590
- Title Cn
- Title En
- A Pilot Comparative Bioavailability Study of Levodopa Administered Via Levodopa Cyclops™ Relative to INBRIJA®
- Bilingual Status
- semi_complete