Parkinson DiseasePhase 1NCT01371682
A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda
A Phase 1 study testing Ropinirole XL in people with Parkinson Disease, run by GlaxoSmithKline at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ropinirole XL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Sep 2009to 2 Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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).
- Female subjects taking hormone replacement therapy.
- Male subjects who are not willing to abstain from sexual intercourse or use a condom during sexual intercourse with pregnant or lactating females. Male subjects not willing to use adequate method of contraception (see Section 8.1.2) if engaging in sexual intercourse with a female who could become pregnant.
- Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication.
- History of sensitivity to heparin, heparin-induced thrombocytopenia.
- Abnormal 12-lead ECG findings include, but are not limited to, the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias. QTc (machine read) > 450 msec on the screening ECG.
- Subjects have had treatment with a new molecular entity (investigational drug) or any other trial during the previous 30 days or five half-lives, whichever is longer. (the washout is from last dose of study medication in the previous study until the first dose of study medication).
- Current evidence of drug abuse or history of drug abuse within one year of enrollment.
- Inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study.
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
- Vulnerable subjects (e.g. persons kept in detention).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and Aranda
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.
Read the detailed description
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.
The manufacturing of ropinirole XL tablets will be moved from the Crawley (UK) manufacturing facility to the Aranda (Spain) manufacturing facility. The tablets manufactured at Aranda will have the same characteristics as those manufactured at Crawley.
The present pharmacokinetic study is designed to assess bioequivalence of ropinirole XL 2 mg tablets manufactured at Aranda vs ropinirole XL 2 mg tablets manufactured at Crawley. Bioequivalence between the two tablets will be tested in healthy subjects and administered in the fasting state.
- Conditions
- Parkinson Disease
- Being tested
- Ropinirole XL
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropinirole XLDrug
Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda.
| Study group | Role | What they receive |
|---|---|---|
| Session 1 | Other | Ropinirole manufactued at Crawley will be compared to that manufactured at Aranda Receives: Drug: Ropinirole XL |
| Session 2 | Other | Ropinirole manufactured at Crawley will be compared to that manufactured at Aranda. Receives: Drug: Ropinirole XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
BP measures will a Systolic BP \&; Diastolic BP (Hg mm). ECG levels will be taken looking at QTc measures. Vital signs will include blood pressur and pulse rate will be recorded at pre-dose and at 1, 2, 4, 6, 12 and 24 hours post-dose of ropinirole
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study start18 Sep 2009
- Primary completion2 Dec 2009
- Study completion2 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371682
- Sponsor's protocol ID
- 112771
- Status last verified
- Jun 2018
- First submitted
- 10 Jun 2010
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and Aranda
- ClinicalTrials.gov ID
- NCT01371682
- Acronym / sponsor ID
- 112771
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2009 (actual)
- Primary completion
- 2 Dec 2009 (actual)
- Study completion
- 2 Dec 2009 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The manufacturing of ropinirole XL tablets will be moved from the Crawley (UK) manufacturing facility to the Aranda (Spain) manufacturing facility. The tablets manufactured at Aranda will have the same characteristics as those manufactured at Crawley.
The present pharmacokinetic study is designed to assess bioequivalence of ropinirole XL 2 mg tablets manufactured at Aranda vs ropinirole XL 2 mg tablets manufactured at Crawley. Bioequivalence between the two tablets will be tested in healthy subjects and administered in the fasting state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Session 1 | Other | Drug: Ropinirole XLRopinirole manufactued at Crawley will be compared to that manufactured at Aranda |
| Session 2 | Other | Drug: Ropinirole XLRopinirole manufactured at Crawley will be compared to that manufactured at Aranda. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropinirole XLRopinirole XL manufactured at Crawley will be compared to that manufactued at Aranda. | Drug | Session 1, Session 2 |
Primary outcome
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.
Time frame: 6 months
PK parameters used to measure this change : AUC(0-infinity), AUC(0-t), Cmax, tmax, lambda - z and t1/2
1 secondary outcome
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.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- BackgroundGSK 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 112771 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ropinirole XL in people with Parkinson Disease, run by GlaxoSmithKline at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.