Neuss, North Rhine-Westphalia, Germany
NCT Number: NCT00881894
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes Deliver Equivalent Drug Amount to the Body.
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.
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Rotigotine transdermal patch
DrugRotigotine 4.5mg/10cm^2 patch applied for 24 hours
Other names: Neupro®
Primary outcomes
-
AUC(0-tz) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application
The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.
-
Cmax of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The Cmax is the maximum plasma concentration.
Secondary outcomes
-
AUC(0-∞) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity.
-
AUC(0-tz)Norm (Apparent Dose) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The AUC(0-tz)Norm (Apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).
-
AUC(0-tz)Norm (BW) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The AUC(0-tz)Norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).
-
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The Cmax,Norm (Apparent dose) is the maximum plasma concentration normalized by apparent dose.
-
Cmax,Norm (BW) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The Cmax,Norm (BW) is the maximum plasma concentration normalized by body weight (kg).
-
Tmax of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The Tmax is the time to reach a maximum plasma concentration after patch application.
-
MRT of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24(before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The MRT is the mean residence time.
-
λz of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The λz is the rate constant of elimination.
-
t1/2 of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The t1/2 is the terminal half- life.
-
CL/f of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The CL/f is the apparent total body clearance.
-
Apparent Dose
Time frame: 48 hours
Apparent dose of unconjugated rotigotine in mg. The Apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.
Sponsors and collaborators
Lead sponsor
UCB Pharma
Industry
Registry information
Official study title
Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm^2) From 2 Different Manufacturing Processes
Important dates
- Study start
- 2008
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Apr 15, 2009
- Registry last updated
- Oct 27, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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