None listed
Conditions
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).
Interventions
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 applic
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.
Sponsors
INCResearch Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed