Trials / Completed
CompletedNCT03589066
Pharmacokinetic Study of LY03003 in Patients With Parkinson's Disease
An Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's Disease
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Luye Pharma Group Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1, open-label, parallel-group study to evaluate rotigotine pharmacokinetics, safety and tolerability following a single intramuscular dose of one of two different formulations of LY03003 in patients with Parkinson's disease.
Detailed description
This study is designed to evaluate and compare the rotigotine pharmacokinetic profile of a single 28 mg intramuscular dose of LY03003 Formulation A and LY03003 Formulation B. The secondary objective of the trial is to evaluate the safety and tolerability of LY03003 Formulation A and LY03003 Formulation B following a single 28 mg IM dose administered to patients with Parkinson's Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LY03003 | 28 mg intramuscular suspension |
Timeline
- Start date
- 2018-05-15
- Primary completion
- 2018-10-31
- Completion
- 2018-10-31
- First posted
- 2018-07-17
- Last updated
- 2018-11-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03589066. Inclusion in this directory is not an endorsement.