HealthyPhase 1NCT01627847
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
A Phase 1 study testing Ropinirole in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy human subjects aged between 18 and 45 years (including both).
- Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
- Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
- Subjects having normal 12-lead electrocardiogram (ECG).
- Subjects having normal chest X-Ray (PIA view).
- Subjects able to communicate effectively.
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- Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- Female subjects who are postmenopausal or surgically sterile.
- Female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,intrauterine device (IUD) or abstinence.
Who cannot join
- Subjects having contraindications or hypersensitivity to ropinirole or domperidone or related group of drugs.
- History or presence of any medical condition or disease according to the opinion of the physician.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
- Difficulty with donating blood.
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- Difficulty in swallowing solids like tablets or capsules.
- Systolic blood pressure less than 110mm Hg or more than 140 mm Hg.
- Diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50 beats/minute or more than 100 beats/minute.
- Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.
- Major illness during 3 months before screening.
- Participation in a drug research study within past 3 months.
- Donation of blood in the past 3 months before screening.
- Female subjects demonstrating a positive pregnancy screen.
- Female subjects who are currently breast-feeding.
- Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).
Trial locations and contacts
1 site in 1 country.
India1 site
GVK Biosciences Pvt. Ltd
Ameerpet, Hyderabad, Andhra Pradesh, 500 038
About this study
Official title: Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Oral Bioequivalence Study of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India With REQUIP@ XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of Glaxosmithkline, USA, in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
Read the detailed description
The objective of this study was to determine the single-dose oral bioequivalence of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India with REQUIP® XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fed condition.
- Conditions
- Healthy
- Being tested
- Ropinirole
- Keywords
- Bioequivalence, Ropinirole Hydrochloride, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopiniroleDrug
Also called Requip
| Study group | Role | What they receive |
|---|---|---|
| Ropinirole | Experimental | Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Ropinirole |
| Requip | Active comparator | Requip XL Tablets 2 mg of Glaxosmithkline, USA Receives: Drug: Ropinirole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve(AUC)
Measured: Pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 3.00,4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00,20.00, 24.00, 30.00, 36.00, 48.00 and 60.00 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Naba Kr Talukdar, MD, Principal investigator, GVK Biosciences Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627847
- Sponsor's protocol ID
- 035-09
- Status last verified
- Jan 2010
- First submitted
- 22 Jun 2012
- Last updated
- 28 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Oral Bioequivalence Study of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India With REQUIP@ XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of Glaxosmithkline, USA, in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
- ClinicalTrials.gov ID
- NCT01627847
- Acronym / sponsor ID
- 035-09
- Conditions
- Healthy
- Keywords
- Bioequivalence, Ropinirole Hydrochloride, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Jun 2012 (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, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
Detailed description
The objective of this study was to determine the single-dose oral bioequivalence of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India with REQUIP® XL (Ropinirole Hydrochloride Extended Release) 2 mg Tablets of Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fed condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropinirole | Experimental | Drug: RopiniroleRopinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited |
| Requip | Active comparator | Drug: RopiniroleRequip XL Tablets 2 mg of Glaxosmithkline, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy human subjects aged between 18 and 45 years (including both).
- Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.
- Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.
- Subjects having normal 12-lead electrocardiogram (ECG).
- Subjects having normal chest X-Ray (PIA view).
Key exclusion criteria (17 listed)
- Subjects having contraindications or hypersensitivity to ropinirole or domperidone or related group of drugs.
- History or presence of any medical condition or disease according to the opinion of the physician.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- History or presence of significant alcoholism or drug abuse in the past one year.
- History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).
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 |
|---|---|---|
| RopiniroleAlso: Requip | Drug | Requip, Ropinirole |
Primary outcome
Area under curve(AUC)
Time frame: Pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 3.00,4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00,20.00, 24.00, 30.00, 36.00, 48.00 and 60.00 hours after dosing.
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 28 Sep 2012.
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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.
Dr. Naba Kr Talukdar, MD principal investigator
GVK Biosciences Pvt. Ltd.
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 in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 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 28 Sep 2012. 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 India. 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?
Area under curve(AUC) (time frame: Pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 3.00,4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00,20.00, 24.00, 30.00, 36.00, 48.00 and 60.00 hours after dosing.). 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 28 Sep 2012.