A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda

NCT01371682 | Completed Phase 1

• 1 other identifier: 112771
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, randomised, two-period crossover, single dose study to demonstrate bioequivalence between the extended release 2 mg ropinirole XL tablets manufactured at two different sites in healthy subjects. Dosing will be under fasting conditions and there will be a minimum one week washout between doses. Domperidone will be administered to control dopaminergic side effects. Pharmacokinetic samples will be taken following each dose. Safety assessments will include screening and follow-up vital signs, ECGs and safety laboratory tests. Vital signs and adverse events will be monitored periodically throughout the study.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• PK samples will be measured for each formulation and compared between sites. The units of measure for this will include PK parameters, for example, Bioavailability, clearance and volume of distribution and Area under the curve.

  PK parameters used to measure this change : AUC(0-infinity), AUC(0-t), Cmax, tmax, lambda - z and t1/2

  6 months

Secondary Outcomes (1)

• Safety values including Vital signs, BP, ECG values will be taken from the study for each cohort dosed with each formulation. The change in values will be compared from each formulation and any change bewteeen the two cohorts will be examined.

  6 months

Study Arms (2)

Session 1

OTHER

Ropinirole manufactued at Crawley will be compared to that manufactured at Aranda

Drug: Ropinirole XL

Session 2

OTHER

Ropinirole manufactured at Crawley will be compared to that manufactured at Aranda.

Drug: Ropinirole XL

Interventions

Ropinirole XL DRUG

Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda.

Session 1; Session 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female healthy subjects aged between 18 and 50 years of age inclusive at dosing.
• Body mass index of 19 to 30 kg/m2, with a body weight of at least 50 kg.
• No abnormality on clinical examination.
• No abnormality revealed by the clinical chemistry or haematology examination at the pre study medical examinationA normal 12 lead ECG at the pre study screening.
• QTc interval of \< 450msec at screening.
• Normal systolic (100 140mmHg) and diastolic (\<90mmHg) blood pressure (supine) at pre study screening.
• AST, ALT and alkaline phosphatase within the laboratory reference range and bilirubin £ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Subjects must have provided written informed consent prior to performing any assessments.A female subject is eligible to participate if she is of:Choose one or both of criteria below depending on requirements of study:Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\]. Since co-administration of HRT with ropinirole has been shown to decrease the clearance of ropinirole, subjects on hormone replacement therapy (HRT) will be excluded.Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to continue using the same method of contraception until at least one month after completion of the study (i.e. one month after the follow-up visit).
• Male subjects must agree to use one of the contraception methods

You may not qualify if:

• Any clinically relevant abnormality identified on the screening history and physical or laboratory examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
• 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 or to domperidone or a personal history of lactose intolerance.
• History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
• 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.
• History of surgical procedures that might affect the absorption of ropinirole (e.g., partial/total gastrectomy, cholecystectomy).
• The subject has received prescription drugs within 14 days or 5 half-lives (whichever is longer) or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study or compromise safety.
• Systolic BP \> 140 mm Hg and/or Diastolic BP \> 90 mm Hg at screening or pre-dose.
• A history of moderate or severe dizziness, syncope, or orthostatic hypotension, defined as a fall in blood pressure after rising from the supine to erect posture, of \>/= 30 mmHg for systolic pressure and \>/= 20 mmHg for diastolic pressure at screening.
• History of excessive regular alcohol consumption within 6 months of screening defined as An average weekly intake of \>21 units for males or \> 14 units for females. One unit is equivalent to a half-pint (220mL) of beer, 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
• Subjects who smoke \>20 cigarettes per day and those who will not abstain from smoking or maintain a constant smoking habit for 14 days before dosing until 72 hours after the last dose.
• Positive urine drug screen (UDS) including alcohol and cotinine (for non-smokers) at screening or pre-dose visits.
• Positive hepatitis B virus, hepatitis C virus or Human Immunodeficiency Virus (HIV) test at screening. If documented negative test results have been obtained within the last 2 months, it will not be necessary to repeat these tests.
• Positive serum or urine beta-human chorionic gonadotropin (b-hCG) test (females).
• Women who are pregnant, lactating, or planning to become pregnant.
• Female subjects not willing to use proposed contraceptive methods (see Section 8.1.1).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Antwerp, 2060, Belgium

Location

Related Publications (1)

• GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary.

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 112771 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Parkinson Disease

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: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 13, 2011
• Study Start: September 18, 2009
• Primary Completion: December 2, 2009
• Study Completion: December 2, 2009
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)