HealthyPhase 1NCT00829504

Ropinirole 0.25 mg Tablets Under Fasting Conditions

A Phase 1 study testing Ropinirole HCl 0.25 mg Tablets and Requip® 0.25 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ropinirole HCl 0.25 mg Tablets and Requip® 0.25 mg Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Oct 2004to Oct 2004
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males and/or females who were between 18 and 45 years old

Who cannot join

If female, pregnant, lactating or likely to become pregnant during this study.
History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g. Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug hypersensitivity of intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
History of dizziness, lightheadedness or fainting upon standing.
Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, hyper/hypotension, arrythmia, tachycardia, seizure disorder or glaucoma.
Presence of gastrointestinal disease or history of malabsorption within the last year.
History of psychiatric disorders occuring within the last two years that required hospitalization or medication.

Show all 16Show fewer

Presence of a medical condition requiring regular treatment with prescription drugs.
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
Receipt of any drug as part of a research study within 30 days prior to dosing.
Drug or alcohol addiction requiring treatment in the past 12 months.
Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within the past 14 days prior to dosing.
Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
Positive test results for drugs of abuse at screening.
Tobacco user within 90 days of the first study date.
Unable, or unwilling to tolerate multiple venipunctures.
Difficulty fasting or eating the standard meals that will be provided.

Trial locations and contacts

1 site in 1 country.

United States1 site

Novum Pharmaceutical Research Services
Houston, Texas, 77042

Other trials in United States

About this study

Official title: The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fasting Conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropinirole HCl 0.25 mg TabletsDrug
1 x 0.25 mg
Requip® 0.25 mg TabletsDrug
1 x 0.25 mg

Study groups in NCT00829504
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Ropinirole HCl 0.25 mg Tablets
2	Active comparator	Not described Receives: Drug: Requip® 0.25 mg Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax.
Measured: Blood samples collected over a 24 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Measured: Blood samples collected over a 24 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Measured: Blood samples collected over a 24 hour period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Oct 2004

First posted27 Jan 2009 (estimated)
Study startOct 2004
Primary completionOct 2004
Study completionOct 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00829504
Sponsor's protocol ID: 10436008
Status last verified: Sep 2009
First submitted: 26 Jan 2009
Last updated: 11 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fasting Conditions.
ClinicalTrials.gov ID: NCT00829504
Acronym / sponsor ID: 10436008
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Oct 2004 (actual)
Study completion: Oct 2004 (actual)
First posted: 27 Jan 2009 (estimated)
Results: Posted 18 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Ropinirole HCl 0.25 mg Tablets
2	Active comparator	Drug: Requip® 0.25 mg Tablets

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males and/or females who were between 18 and 45 years old

Key exclusion criteria (16 listed)

If female, pregnant, lactating or likely to become pregnant during this study.
History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g. Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug hypersensitivity of intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
History of dizziness, lightheadedness or fainting upon standing.
Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, hyper/hypotension, arrythmia, tachycardia, seizure disorder or glaucoma.
Presence of gastrointestinal disease or history of malabsorption within the last year.

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 HCl 0.25 mg Tablets1 x 0.25 mg	Drug	1
Requip® 0.25 mg Tablets1 x 0.25 mg	Drug	2

Primary outcome

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples collected over a 24 hour period.
Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples collected over a 24 hour period.
Bioequivalence based on AUC0-t.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples collected over a 24 hour period.
Bioequivalence based on AUC0-inf.

Results and safety

Results posted to the registry on 18 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test (Ropinirole HCl) First	22	21
Reference (Requip®) First	22	22

Primary outcome: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 24 hour period.. Mean (Standard Deviation). Unit: pg/mL

Measure	Test (Ropinirole HCl) n = 40	Reference (Requip®) n = 40
Value	552.1 (219.01)	546.5 (205.72)

Test (Ropinirole HCl) vs Reference (Requip®): Ratio of the T/R geometric mean x 100: 100.16 (90% CI 95.5 to 105.04)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Time frame: Blood samples collected over a 24 hour period.. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Test (Ropinirole HCl) n = 40	Reference (Requip®) n = 40
Value	4190.92 (2290.13)	4062.99 (2073.39)

Test (Ropinirole HCl) vs Reference (Requip®): Ratio of the T/R geometric mean x 100: 101.76 (90% CI 95.45 to 108.49)

Population analysed: All participants that completed the study had their samples analyzed.

Primary outcome: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 24 hour period.. Mean (Standard Deviation). Unit: pg*h/mL

Measure	Test (Ropinirole HCl) n = 40	Reference (Requip®) n = 40
Value	4469 (2561.37)	4305.88 (2283.55)

Test (Ropinirole HCl) vs Reference (Requip®): Ratio of the T/R geometric mean x 100: 102.1 (90% CI 95.64 to 109)

Population analysed: All participants that completed the study had their samples analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Soran Hong, M.D. principal investigator

Novum Pharmaceuticals Research Services

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 HCl 0.25 mg Tablets and Requip® 0.25 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

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 1 inclusion and 16 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 11 Sep 2009. 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 United States. 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?

Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 24 hour period.). The study lists 3 primary outcomes in all. 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 NCT00829504.

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 11 Sep 2009.