Phase 1
Completed N=52
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
Healthy
Source: ClinicalTrials.gov NCT00881894 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: AUC(0-tz) of Unconjugated Rotigotine — 3.0168; 3.0635 (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 2 rotigotine transdermal patches from 2 different manufacturing processes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-tz) of Unconjugated Rotigotine |
3.0168; 3.0635 | — |
| PRIMARY Cmax of Unconjugated Rotigotine |
0.14418; 0.15155 | — |
| SECONDARY AUC(0-∞) of Unconjugated Rotigotine |
3.12622; 3.16403 | — |
| SECONDARY AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine |
1.78200; 1.58900 | — |
| SECONDARY AUC(0-tz)Norm (BW) of Unconjugated Rotigotine |
239.241; 243.841 | — |
| SECONDARY Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine |
0.085822; 0.079619 | — |
| SECONDARY Cmax,Norm (BW) of Unconjugated Rotigotine |
11.4391; 12.0441 | — |
| SECONDARY Tmax of Unconjugated Rotigotine |
16.00; 16.00 | — |
| SECONDARY MRT of Unconjugated Rotigotine |
19.012; 18.882 | — |
| SECONDARY λz of Unconjugated Rotigotine |
0.153848; 0.151239 | — |
| SECONDARY t1/2 of Unconjugated Rotigotine |
4.7665; 4.7128 | — |
| SECONDARY CL/f of Unconjugated Rotigotine |
1825.38; 1822.13 | — |
| SECONDARY Apparent Dose |
1.676; 1.890 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy White, male volunteers between 18 and 55 years of age (inclusive).
- BMI between 19 and 28 kg/m² (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.
- Thickly hair-covered abdomen resulting in difficulties in finding appropriate patch application sites
Data sourced from ClinicalTrials.gov (NCT00881894). 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.