Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects

NCT01435915 | Completed Phase 1

• 1 other identifier: 112558
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Profile of Pharmacokinetics

  Cmax, AUC (0-24), AUC(0-inf)

  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

• Profile of Pharmacokinetics

  Css\_max, Css\_min and AUCss

  predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing

Secondary Outcomes (2)

• Profile of Pharmacokinetics

  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

• Composition of Pharmacokinetics

  predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing

Study Arms (1)

Subjects receiving ropinirole

EXPERIMENTAL

Eligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7.

Drug: Ropinirole

Interventions

Ropinirole DRUG

Ropinirole 2 milligrams once daily prolonged release tablet will be given at 24-hour intervals in the morning. Single and repeat dose treatment periods will be separated by 7 days of washout period.

Subjects receiving ropinirole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
• 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.
• 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.
• 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.
• 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.
• 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.
• Positive screen for addictive drugs and tobacco.
• Participation in a trial with any drug within the 1 month before the start of the study.
• 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.
• Positive pre-study screening result for hepatitis B antigen, hepatitis C antibody and HIV-1/2 antibodies.
• Pregnancy and/or lactation;
• 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.
• Female subjects with positive serum hCG test result at screening or on Days 1 of both study phases with positive urine HCG test.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Beijing, 100032, China

Location

Related Links

• Results for study 112558 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Parkinson Disease

Interventions

ropinirole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 19, 2011
• Study Start: June 28, 2010
• Primary Completion: August 5, 2010
• Study Completion: August 5, 2010
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

CN (1)