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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A first-in-man study to compare an investigational ropinirole transdermal patch formulation with a ropinirole oral tablet (Requip [Registered Trademark] XL [Trademark]) in healthy volunteers.
Scientific title
An Exploratory, Open-Label, Single- and Repeat-Dose, Randomized, Two-Period, Cross-Over Study in Healthy Subjects to Assess the Pharmacokinetic Profiles, Safety and Tolerability of a Transdermal Patch Formulation of Ropinirole Compared to Oral Ropinirole
Secondary ID [1] 281137 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 287308 0
Condition category
Condition code
Neurological 287643 287643 0 0
Parkinson's disease

Study type
Description of intervention(s) / exposure
The interventions being used include the Ropinirole transdermal patch - 8 cm2 transdermal patch, containing 3.84 mg of ropinirole and targeted to deliver 2 mg with each daily application and Requip[Registered Trademark] XL[Trademark] (ropinirole extended release tablets, 2 mg) - 2mg oral tablet.

The study will be conducted in 24 healthy volunteers divided into 2 treatment groups that will be run in parallel (at the same time).

Group 1: will receive a single ropinirole transdermal patch application and a single Requip[Registered Trademark] XL[Trademark] tablet (or vice-versa) separated by a 3-day washout period

Group 2: will receive 5 consecutive daily ropinirole transdermal patches and 5 consecutive daily Requip[Registered Trademark] XL[Trademark] tablets (or vice-versa) separated by a 3-day washout period.
Intervention code [1] 285597 0
Treatment: Drugs
Comparator / control treatment
Requip[Registered Trademark] XL[Trademark] (ropinirole extended release tablets, 2 mg) - 2mg oral tablet.
Control group

Primary outcome [1] 287892 0
The primary objective of this study is to assess the pharmacokinetic (PK) profiles of ropinirole following single and repeat (5) administrations of the Ropinirole Transdermal Patch compared with single and repeat doses of oral Requip XL extended release tablets.
Timepoint [1] 287892 0
Group 1: PK sampling will start on each treatment day (ie, Days 1 and 5) according to the following schedule: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, and 48 h after dosing (with the transdermal patch or the oral tablet).

Group 2: Based on randomization, the PK sampling schedule is as follows:
Ropinirole Transdermal Patch:
Day 1 or 9: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 22 h after application of the first patch
Days 2-4 or Days 10-12: predose, and 3, 6, and 9 h after application
Day 5 or 13: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, and 48 h after application of the last (5th) patch
Requip XL tablet:
Days 1-4 or Days 9-12: predose
Day 5 or 13: predose, and 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, and 48 h after dosing
Secondary outcome [1] 298994 0
To assess safety and tolerability of the Ropinirole Transdermal Patch including assessment of skin irritation using a modified Draize scale.
Timepoint [1] 298994 0
Skin irritation will be assessed at 1 and 24 h after removal of each patch.
Secondary outcome [2] 298995 0
To assess adhesion of the Ropinirole Transdermal Patch using observations that will be quantified using the scoring system described in the Protocol (Patch Adhesion Scale).
Timepoint [2] 298995 0
Patch adhesion will be assessed at 6, 12, and 18 h after application and immediately prior to removal of each patch.

Key inclusion criteria
1. Healthy male or female subjects 18 to 40 years of age, inclusive.
2. Subjects must be non-smokers, as defined by not smoking for at least 1 year prior to screening.
3. Body mass index (BMI) within the range of 18 to 29 kg/m2, inclusive, and a minimum weight of at least 50 kg.
4. Free of any dermatologic conditions (eg, psoriasis, eczema), excessive hair or skin allergies and sensitivities that may compromise the subject’s ability to wear the investigational product at any of the application sites for the specified duration of treatment.
5. Female subjects of childbearing potential must be practicing abstinence or using and willing to continue using a medically acceptable form of birth control for at least 1 month prior to dosing and for at least 30 days after the last study drug administration, or until their next menstrual period.
6. Female subjects must have a negative serum pregnancy test prior to dosing.
7. Must be able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
8. Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
9. Must be willing and able to abide by all study requirements and restrictions.
Minimum age
18 Years
Maximum age
40 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. A history or presence of drug or alcohol dependence (excluding caffeine), including subjects who have ever been in a drug rehabilitation program based on medical history.
2. Clinically significant abnormalities as judged by the investigator or designee and determined by physical examination, medical history, 12-lead electrocardiogram (ECG), vital signs, laboratory values including serum kidney and liver function tests.
3. Presence of postural hypotension (determined through examination by the investigator or designee), or recent history of severe dizziness or fainting due to postural hypotension on standing.
4. Subjects with a history of seizures, asthma or obstructive pulmonary disease.
5. Presence or history of a psychiatric disorder, organic brain disorder, or seizure disorder deemed clinically significant by the investigator or designee.
6. Presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (including ulcers or gastrointestinal bleeding), endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results.
7. Abnormality (eg, scar, tattoo) or unhealthy skin (eg, burns, wounds) at the application site, according to examination by the investigator at screening or admission to the treatment period of the study.
8. An existing chronic skin disease or history of skin disease at the application site within the 30 days prior to screening.
9. Use of any drugs containing estrogens within 30 days prior to first drug administration and throughout the study.
10. Use of any medications that are inhibitors or inducers of CYP1A2 or CYP3A4 within 14 days prior to first drug administration and throughout the study.
11. Use of any prescription medications or natural health products (except vitamin or mineral supplements, or acceptable forms of birth control) within 14 days prior to first drug administration or throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity, or compromise the safety of the subject.
12. Use of a non-prescription drug within 7 days prior to the first drug administration. Subjects who have taken over-the-counter medication may still be entered into the study, if in the opinion of the investigator or designee, the medication received will not interfere with the study procedures or data integrity, or compromise the safety of the subject.
13. Positive urine drug screen prior to dosing.
14. Positive alcohol test prior to dosing.
15. Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 30 days of last study drug administration.
16. History of allergy or hypersensitivity to ropinirole, ropinirole hydrochloride or to ergot or non-ergoline derivatives, related drugs, any of the drug excipients or other drug product components, or to indelible ink.
17. Positive for Hepatitis B, Hepatitis C, or the human immunodeficiency virus (HIV).
18. Donation of blood or loss of blood (> 100 mL) within 30 days prior to the first administration of study drug.
19. Subject has a personal responsibility or already confirmed appointment(s) or court dates that would in any way prevent him/her from meeting the time commitments and visits required by the study.
20. Treatment with any investigational drug within 30 days prior to first study-drug administration.
21. A subject who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a randomized, open-label study. Within each treatment group, subjects will be randomized in a 1:1 ratio to one of two treatment sequences, as follows:
*Patch, 3-day washout, tablet
*Tablet, 3-day washout, patch
Study drug will not be blinded.

Upon confirmation of eligbility subjects will be assigned (by the PI) the next sequential randomisation number from the randomisation list which is held by the Pharmacist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (using a computerised sequence generation) to one of two treatment sequences in a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285918 0
Commercial sector/Industry
Name [1] 285918 0
Teikoku Pharma USA, Inc
Address [1] 285918 0
1718 Ringwood Ave
San Jose, CA 95131
Country [1] 285918 0
United States of America
Primary sponsor type
Commercial sector/Industry
INCResearch Australia Pty Ltd
124 Lipson Street
Port Adelaide SA 5015
Secondary sponsor category [1] 284741 0
Name [1] 284741 0
Address [1] 284741 0
Country [1] 284741 0

Ethics approval
Ethics application status
Ethics committee name [1] 287947 0
Bellberry Limited
Ethics committee address [1] 287947 0
229 Greenhill Rd
Dulwich SA 5065
Ethics committee country [1] 287947 0
Date submitted for ethics approval [1] 287947 0
Approval date [1] 287947 0
Ethics approval number [1] 287947 0

Brief summary
The purpose of this research study is to compare the concentration of Ropinirole in the blood after application of the patch to the concentration of Ropinirole in the blood after taking the tablet formulation.

The study will also look at how safe the Ropinirole patch is, as well as how well subjects tolerate the dose delivered transdermally (study drug is absorbed through the skin).
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34652 0
Dr Andrew Redfern
Address 34652 0
Linear Clinical Research - Level 1, B Block, Hospital Avenue, Nedlands, Perth, 6009 Western Australia
Country 34652 0
Phone 34652 0
+61 8 6382 5100
Fax 34652 0
Email 34652 0
Contact person for public queries
Name 17899 0
Ms Sally Johnsson
Address 17899 0
INC Research - Suite 1, Level 2, 924 Pacific Highway, Gordon, NSW 2072, Australia
Country 17899 0
Phone 17899 0
+61(0)2 8437 9237
Fax 17899 0
+61(0)2 8437 9299
Email 17899 0
Contact person for scientific queries
Name 8827 0
Dr Kenneth D. Krantz, M.D., Ph.D
Address 8827 0
1718 Ringwood Ave
San Jose, CA 95131
Country 8827 0
United States of America
Phone 8827 0
Fax 8827 0
Email 8827 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary