Phase 1
Completed N=50
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
Healthy Volunteers
Source: ClinicalTrials.gov NCT01059903 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: AUC(0-tz) of Unconjugated Rotigotine — 5.2704; 5.4724 ng/ mL*h
Summary
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-tz) of Unconjugated Rotigotine |
5.2704; 5.4724 | — |
| PRIMARY Cmax of Unconjugated Rotigotine |
0.26156; 0.25774 | — |
| PRIMARY AUC(0- ∞) of Unconjugated Rotigotine |
5.36933; 5.56925 | — |
| SECONDARY AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine |
2.56504; 2.66067 | — |
| SECONDARY AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine |
412.942; 434.101 | — |
| SECONDARY AUC(0- ∞) Norm (Apparent Dose) |
2.62042; 2.71397 | — |
| SECONDARY AUC(0- ∞) Norm (Body Weight) |
420.811; 441.761 | — |
| SECONDARY Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine |
0.128863; 0.126144 | — |
| SECONDARY Cmax, Norm (Body Weight) of Unconjugated Rotigotine |
20.4935; 20.4489 | — |
| SECONDARY Tmax of Unconjugated Rotigotine |
16.78; 15.75 | — |
| SECONDARY Mean Residence Time (MRT) of Unconjugated Rotigotine |
18.473; 18.186 | — |
| SECONDARY Rate Constant of Elimination (λz) of Unconjugated Rotigotine |
0.162587; 0.165400 | — |
| SECONDARY Terminal Half-Life (t1/2) of Unconjugated Rotigotine |
4.4523; 4.3752 | — |
| SECONDARY Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine |
1125.11; 1041.47 | — |
| SECONDARY Apparent Dose |
1.970; 2.036 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy White, male volunteers between 18 and 55 years of age (inclusive).
- BMI between 19 and 28 kg/m^2 (inclusive)
Exclusion Criteria
- Previous participation in a clinical study with Rotigotine
- History or current condition of epilepsy and/or seizures
- Known clinically relevant allergy or known/suspected clinically relevant drug hypersensitivity
- History of significant skin hypersensitivity to adhesives or other transdermal products or recently unresolved contact dermatitis
- History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
- Clinically relevant abnormality in physical examination, ECG, vital signs or safety laboratory examinations
- Positive HIV, hepatitis B or C test or positive alcohol or drug test
- Relevant hepatic or renal dysfunction
- Intake of medication that might interfere with the test drug within 2 weeks prior to dosing
Data sourced from ClinicalTrials.gov (NCT01059903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.