Phase 1
Completed N=40
Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body
Healthy Volunteers
Source: ClinicalTrials.gov NCT00957944 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcomePrimary: AUC(0-tz) of Unconjugated Rotigotine — 4.3899; 4.4255 (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 sites.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-tz) of Unconjugated Rotigotine |
4.3899; 4.4255 | — |
| PRIMARY Cmax of Unconjugated Rotigotine |
0.21103; 0.20386 | — |
| PRIMARY AUC(0-∞) of Unconjugated Rotigotine |
4.51237; 4.55159 | — |
| SECONDARY AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine |
2.23980; 2.23035 | — |
| SECONDARY AUC(0-tz) Norm (BW) of Unconjugated Rotigotine |
364.930; 367.452 | — |
| SECONDARY AUC(0-∞) Norm (Apparent Dose) |
2.30523; 2.29747 | — |
| SECONDARY AUC(0-∞) Norm (BW) |
375.224; 378.003 | — |
| SECONDARY Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine |
0.108148; 0.103965 | — |
| SECONDARY Cmax,Norm (BW) of Unconjugated Rotigotine |
17.6070; 16.9748 | — |
| SECONDARY Tmax of Unconjugated Rotigotine |
16.00; 16.00 | — |
| SECONDARY MRT of Unconjugated Rotigotine |
19.914; 19.980 | — |
| SECONDARY λz of Unconjugated Rotigotine |
0.129745; 0.125217 | — |
| SECONDARY t1/2 of Unconjugated Rotigotine |
5.5408; 5.7878 | — |
| SECONDARY CL/f of Unconjugated Rotigotine |
1185.98; 1227.56 | — |
| SECONDARY Apparent Dose |
1.932; 1.927 | — |
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 (NCT00957944). 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.