Study in Healthy Volunteers to Prove That Two Rotigotine... | NCT00957944

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	Experimental	Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days	Drug: rotigotine transdermal patch (Neupro®)
Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)	Experimental	Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days	Drug: rotigotine transdermal patch (Neupro®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rotigotine transdermal patch (Neupro®)	Drug	Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND) Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.
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.
AUC(0-∞) of Unconjugated Rotigotine	The AUC(0-∞) 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.

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Name	Affiliation	Role
UCB Clinical Trial Call center	+1 877 822 9493 (UCB)	Study Director

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)	Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
BG001	Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)	Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00118 BG00238

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.0± 11.7 BG00132.8± 7.2 BG00235.0± 9.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Body Mass Index (BMI)

BMI= Weight/(Height)^2

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00025.03± 2.16 BG00125.87± 1.77

Height

Mean

Standard Deviation

meter (m)

Title

Denominators

Categories

Title	Measurements
	BG0001.82± 0.07 BG0011.82± 0.08 BG002

Weight

Mean

Standard Deviation

kilogram (kg)

Title

Denominators

Categories

Title	Measurements
	BG00083.18± 9.62 BG00185.33± 8.75 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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 Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)*h

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG00038 OG00138

Title

Denominators

Categories

Title	Measurements
	OG0004.3899± 1.7959 OG0014.4255± 2.3969

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Bioequivalence testing by using the 90% Confidence Interval (CI).	ANOVA	ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).			ratio of geometric LS- Means	1.0302				90	0.9693	1.0951			Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.	Yes	Non-Inferiority or Equivalence

Primary

Cmax of Unconjugated Rotigotine

The Cmax is the maximum plasma concentration.

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

ng/ mL

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Primary

AUC(0-∞) of Unconjugated Rotigotine

The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)*h

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

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 Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)*(h/ 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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants

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 Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)*h*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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants

Secondary

AUC(0-∞) Norm (Apparent Dose)

The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)*(h/ 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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

AUC(0-∞) Norm (BW)

The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)*h*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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine

The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL)/ 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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

Cmax,Norm (BW) of Unconjugated Rotigotine

The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

(ng/ mL) * 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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

Tmax of Unconjugated Rotigotine

The tmax is the time to reach a maximum plasma concentration after patch application.

Pharmacokinetic Set (PKS)

Posted

Median

Full Range

hour (h)

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

MRT of Unconjugated Rotigotine

The MRT is the mean residence time.

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

hour (h)

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

λz of Unconjugated Rotigotine

The λz is the rate constant of elimination.

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

1/ hour (1/h)

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

t1/2 of Unconjugated Rotigotine

The t1/2 is the terminal half- life.

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

hour (h)

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Secondary

CL/f of Unconjugated Rotigotine

The CL/f is the apparent total body clearance.

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

L/h

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.

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

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.

Pharmacokinetic Set (PKS)

Posted

Mean

Standard Deviation

48 hours

ID	Title	Description
OG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
OG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment A (Test: PR 2.1.1 WCL)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours			0	39	5	39
EG001	Treatment B (Reference: PR 2.1.1 AND)	Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours			0	40	6	40

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected40 at risk
Application Site Pruritus	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected39 at risk EG0013 events3 affected40 at risk
Fatigue	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected40 at risk
Hot Flush	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected40 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected40 at risk
Sleep Disorder	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected40 at risk