Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches 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 (4.5mg/10cm2) Comparing Two Different Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059903
• Other study ID #: SP0987
• Status: Completed
• Phase: Phase 1
• First received: January 28, 2010
• Last updated: May 15, 2012
• Start date: January 2010
• Est. completion date: March 2010

Study information

• Verified date: May 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 two Rotigotine patches of two different formulations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• 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/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

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
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 concentration-time curve from zero up to the last analytically quantifiable concentration.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Primary	Cmax of Unconjugated Rotigotine	The Cmax is the maximum plasma concentration.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	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	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	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).	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	AUC(0-tz) Norm (Body Weight) 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).	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	AUC(0- 8) Norm (Apparent Dose)	The AUC(0-inf) norm (apparent dose) is the area under the plasma concentration-time curve from zero up to infinity normalized by apparent dose (mg).	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	AUC(0- 8) Norm (Body Weight)	The AUC(0-inf) norm (BW) is the area under the plasma concentration-time curve from zero up to infinity normalized by body weight (kg).	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine	The Cmax, norm (apparent dose) is the maximum plasma concentration normalized by apparent dose (mg).	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Cmax, Norm (Body Weight) of Unconjugated Rotigotine	The Cmax, norm (BW) is the maximum plasma concentration normalized by body weight (kg).	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Tmax of Unconjugated Rotigotine	The tmax is the time to reach maximum plasma concentration after patch application.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Mean Residence Time (MRT) of Unconjugated Rotigotine	The MRT is the mean residence time.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Rate Constant of Elimination (?z) of Unconjugated Rotigotine	The ?z of unconjugated rotigotine is the rate constant of elimination.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Terminal Half-Life (t1/2) of Unconjugated Rotigotine	the t1/2 of unconjugated rotigotine is the terminal half-life, calculated as t1/2=ln2/ ?z.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine	The CL/f of unconjugated rotigotine is the apparent total body clearance.	0 h (predose), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h, and 48 h	No
Secondary	Apparent Dose	Apparent dose of unconjugated rotigotine in mg. The apparent dose was calculated by subtraction of the determined residual content of each rotigotine patch from the nominal content of rotigotine in the patch.	24 hours	No

External Links

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