Clinical trial NCT00957944: Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body
Official title: Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5 mg/10 cm^2) From 2 Different Manufacturing Sites.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Rotigotine
Neupro®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: AUC(0-tz) of Unconjugated Rotigotine
timeFrame: 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.
measure: Cmax of Unconjugated Rotigotine
timeFrame: 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.
measure: AUC(0-∞) of Unconjugated Rotigotine
timeFrame: 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.
Secondary outcomes:
measure: AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine
timeFrame: 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.
measure: AUC(0-tz) Norm (BW) of Unconjugated Rotigotine
timeFrame: 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.
measure: AUC(0-∞) Norm (Apparent Dose)
timeFrame: 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.
measure: AUC(0-∞) Norm (BW)
timeFrame: 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.
measure: Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine
timeFrame: 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.
measure: Cmax,Norm (BW) of Unconjugated Rotigotine
timeFrame: 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.
measure: Tmax of Unconjugated Rotigotine
timeFrame: 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.
measure: MRT of Unconjugated Rotigotine
timeFrame: 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.
measure: λz of Unconjugated Rotigotine
timeFrame: 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.
measure: t1/2 of Unconjugated Rotigotine
timeFrame: 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.
measure: CL/f of Unconjugated Rotigotine
timeFrame: 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.
measure: Apparent Dose
timeFrame: 48 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
state: NRW
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call center
role: STUDY_DIRECTOR
References: