Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957944
• Other study ID #: SP0957
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2009
• Last updated: October 17, 2014
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: April 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• rotigotine transdermal patch (Neupro®)
Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-tz) of Unconjugated Rotigotine	The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.	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.	No
Primary	Cmax of Unconjugated Rotigotine	The Cmax is the maximum plasma concentration.	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.	No
Primary	AUC(0-8) of Unconjugated Rotigotine	The AUC(0-8) is the area under the plasma concentration- time curve from zero up to infinity	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.	No
Secondary	AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	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).	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.	No
Secondary	AUC(0-tz) Norm (BW) of Unconjugated Rotigotine	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).	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.	No
Secondary	AUC(0-8) Norm (Apparent Dose)	The AUC(0-8) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).	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.	No
Secondary	AUC(0-8) Norm (BW)	The AUC(0-8) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).	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.	No
Secondary	Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine	The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).	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.	No
Secondary	Cmax,Norm (BW) of Unconjugated Rotigotine	The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).	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.	No
Secondary	Tmax of Unconjugated Rotigotine	The tmax is the time to reach a maximum plasma concentration after patch application.	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.	No
Secondary	MRT of Unconjugated Rotigotine	The MRT is the mean residence time.	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.	No
Secondary	?z of Unconjugated Rotigotine	The ?z is the rate constant of elimination.	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.	No
Secondary	t1/2 of Unconjugated Rotigotine	The t1/2 is the terminal half- life.	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.	No
Secondary	CL/f of Unconjugated Rotigotine	The CL/f is the apparent total body clearance.	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.	No
Secondary	Apparent Dose	Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.	48 hours	No

External Links

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