Clinical trial NCT01435915: Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
Official title: A Single Dose and Repeat Dose Study to Investigate the Pharmacokinetics of Ropinirole After Single and Multiple Doses of a PR-formulation in Chinese Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR after single and multiple doses of the PR-formulation. It will also investigate the safety and tolerability of ropinirole PR after single and multiple doses of PR-formulation.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult men and women between 18 and 45 years of age, inclusive.
2. Body weight \>=50Kg.
3. Body Mass Index (BMI) 19 - 24 kg/m2.
4. No abnormality on clinical examination.
5. No abnormality revealed by the clinical chemistry or haematology examination at the pre-study medical examination.
6. A normal 12-lead ECG at the pre-study screening.
7. Normal systolic (100-140mmHg) and diastolic (\<90mmHg) blood pressure at pre-study screening.
8. Written informed consent prior to admission to the study.

Exclusion Criteria:

1. Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
2. Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
3. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
4. The subject has received prescribed medication within 7 days prior to the first dosing day, which in the opinion of the principal medical investigator interfered with the study procedures or compromised safety.
5. The subject has received over-the-counter (OTC) medicine within 48 hours prior to the first study day. Subjects who took OTC medication could still be entered into the study, if, in the opinion of the principal/co-investigator, the medication received did not interfere with the study procedures or compromised safety of the subjects.
6. Abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units. One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine.
7. Positive screen for addictive drugs and tobacco.
8. Participation in a trial with any drug within the 1 month before the start of the study.
9. Either blood donation within the previous 3 months, or donation of a quantity of blood within the previous 12 months that would result in the subject having donated more than 1,500mL blood in a period from 12 months before this study up to and including the end of the study.
10. Positive pre-study screening result for hepatitis B antigen, hepatitis C antibody and HIV-1/2 antibodies.
11. Pregnancy and/or lactation;
12. Female subjects of childbearing potential who are intending to become pregnant and/or are not willing to avoid pregnancy by means of barrier contraception methods (i.e. condoms or IUD) during the study from 5 days prior to screening or in the 3 months following the study.
13. Female subjects with positive serum hCG test result at screening or on Days 1 of both study phases with positive urine HCG test.

Primary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24,36,48,72, 96,120,144,168 hours post-dose
measure: Profile of Pharmacokinetics
timeFrame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
Secondary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: pre-dose,1,2,3,4,6,8,10,12,14,16,18,20,22, 24,36,48,72,96,120,144,168hours post-dose
measure: Composition of Pharmacokinetics
timeFrame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
Other outcomes:
Locations:
city: Beijing
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: