Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Rotigotine transdermal patch (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: UCB Pharma Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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
Clinical Details
Official title: Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm2) Comparing Two Different Formulations
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUC(0-tz) of Unconjugated RotigotineCmax of Unconjugated Rotigotine AUC(0- ∞) of Unconjugated Rotigotine
Secondary outcome: AUC(0-tz) Norm (Apparent Dose) of Unconjugated RotigotineAUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine AUC(0- ∞) Norm (Apparent Dose) AUC(0- ∞) Norm (Body Weight) Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine Cmax, Norm (Body Weight) of Unconjugated Rotigotine Tmax of Unconjugated Rotigotine Mean Residence Time (MRT) of Unconjugated Rotigotine Rate Constant of Elimination (λz) of Unconjugated Rotigotine Terminal Half-Life (t1/2) of Unconjugated Rotigotine Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine Apparent Dose
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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
Locations and Contacts
Moenchengladbach, NRW, Germany
Additional Information
Product Information FDA Safety Alerts and Recalls
Starting date: January 2010
Last updated: May 15, 2012
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