Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435915
First received: September 1, 2011
Last updated: September 13, 2012
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: Ropinirole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Profile of Pharmacokinetics [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Cmax, AUC (0-24), AUC(0-inf)

  • Profile of Pharmacokinetics [ Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing ] [ Designated as safety issue: No ]
    Css_max, Css_min and AUCss


Secondary Outcome Measures:
  • Profile of Pharmacokinetics [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Tmax, T1/2, Kel

  • Composition of Pharmacokinetics [ Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing ] [ Designated as safety issue: No ]
    Tmax, Css_av, DF,accumulation ratios (Ro and Rs)


Enrollment: 24
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropinirole Drug: Ropinirole

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435915

Locations
China
GSK Investigational Site
Beijing, China, 100032
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01435915     History of Changes
Other Study ID Numbers: 112558
Study First Received: September 1, 2011
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
China: Food and Drug Administration
China: Ethics Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014