HealthyPhase 1NCT00830219
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed 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.
Trial summary
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions… 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
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 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
- Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of 19-30 kg/m² inclusive and weighing at least 120 lbs.
- Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at least 60 b.p.m.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential, subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom with spermicide, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected or implanted hormonal contraceptives within 180 days of dosing will not be allowed to participate.
Who cannot join
- If female, pregnant, lactating, or likely to become pregnant during the 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 or 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, arrhythmia, tachycardia, seizure disorder or glaucoma.
- Presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
Show all 17Show 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 14 days prior to dosing.
- Positive test results for HIC, Hepatitis B surface antigen or Hepatitis C antibody.
- Positive test results for drugs of abuse at screening.
- Positive serum pregnancy test.
- Tobacco user within 90 days of the first study dose.
- 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
About this study
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.
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, single dose fed
Requip® 0.25 mg TabletsDrug
1 x 0.25 mg, single dose fed
| 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.
- First posted27 Jan 2009 (estimated)
- Study startNov 2004
- Primary completionNov 2004
- Study completionNov 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- So Ran Hong, M.D., Principal investigator, Novum Pharmaceutical Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830219
- Sponsor's protocol ID
- 10436009
- Status last verified
- Sep 2009
- First submitted
- 26 Jan 2009
- Last updated
- 15 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 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 Fed Conditions
- ClinicalTrials.gov ID
- NCT00830219
- Acronym / sponsor ID
- 10436009
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 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.
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.
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 (5 listed)
- Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of 19-30 kg/m² inclusive and weighing at least 120 lbs.
- Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at least 60 b.p.m.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations.
- If female and of child bearing potential, subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom with spermicide, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected or implanted hormonal contraceptives within 180 days of dosing will not be allowed to participate.
Key exclusion criteria (17 listed)
- If female, pregnant, lactating, or likely to become pregnant during the 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 or 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, arrhythmia, 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, single dose fed | Drug | 1 |
| Requip® 0.25 mg Tablets1 x 0.25 mg, single dose fed | 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
So Ran Hong, M.D. principal investigator
Novum Pharmaceutical 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 5 inclusion and 17 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 15 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?
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 15 Sep 2009.