Pharmacokinetic StudyPhase 1NCT01712568
Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets
A Phase 1 study testing Test Product (Ropinirole) and Reference Product (REQUIP ) in people with Pharmacokinetic Study, run by Lupin Ltd. at 1 site in India.
Trial summary
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic Study
- What is being tested?
- Test Product (Ropinirole) and Reference Product (REQUIP )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2008to Oct 2008
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the written informed consent form (ICF) duly signed by the volunteer.
- Healthy human male subjects between 18-45 years Weighing at least 50 kg and with a body mass index (BMI) of 18 kg/m2 and less than or equal to 25 kg/m2 (according to the formula of BMI = weight (kg)/[height (m)]2).
- Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 14 days prior to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- Light-, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex-smokers are defined as someone who completely stopped smoking for at least 3 months.
Who cannot join
- History or presence of significant:
- History of hypersensitivity or idiosyncratic reactions to Ropinirole or any related products.
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse within past one year. IV. Moderate to heavy smoking (>10 cigarettes/day) or consumption of tobacco products.
- History of difficulty in swallowing VI. Clinically significant illness within 4 weeks before the start of the study VII. Asthma, urticaria or other allergic type reactions after taking any medication.
- Blood loss/donation of more than 350 mL within 3 months prior to study dosing or difficulty in donating blood.
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- Participation in another clinical study not involving donation of blood, within the preceding 90 days of study start.
- Subjects who have:
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.
- Pulse rate below 50/min. or above 105/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AN OPEN LABEL, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, BIOEQUIVALENCE STUDY OF ROPINIROLE HYDROCHLORIDE CR 2mg TABLETS OF LUPIN LIMITED, INDIA, COMPARING WITH THAT OF REQUIP XL OF GLAXOSMITHKLINE RESEARCH TRIANGLE PARK, IN HEALTHY ADULT MALE SUBJECTS
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each period. After maintaining at least 10 hours of overnight fast Test or Reference product was administered orally (as per the randomization schedule) to each subject with about 240 mL of water at ambient temperature in each period by trained study personnel.
The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period with a washout period of 7 days between the dosing of two periods. Subjects were continuously monitored for well being i.e., blood pressure, radial pulse and oral temperature before check-in, prior to drug administration and at regular intervals post dose in each period. The concentration of Ropinirole in plasma samples obtained from study subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on obtained drug concentration data, using appropriate software.
- Conditions
- Pharmacokinetic Study
- Being tested
- Test Product (Ropinirole), Reference Product (REQUIP )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product (Ropinirole)Drug
Also called Ropinirole HCl Tablets CR 2mg
one Tablet at "0" hour
Reference Product (REQUIP )Drug
Also called REQUIP XL Tablets
one Tablet at "0" hour
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Drug: Ropinirole Single oral dose of Ropinirole hydrochloride CR 2mg Tablets under fasting conditions Receives: Drug: Test Product (Ropinirole); Drug: Reference Product (REQUIP ) |
| Reference Product | Experimental | Drug: Ropinirole REQUIP XL Tablets (Ropinirole hydrochloride CR 2mg)commercial formulation under fasting conditions Receives: Drug: Test Product (Ropinirole); Drug: Reference Product (REQUIP ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the pharmacokinetic (PK) profile for Ropinirole in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
Measured: Predose, 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours
Secondary outcomes (1)
Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations and electrocardiograms
Measured: From baseline day 0 through to post study Follow-up (maximum 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic StudyStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lupin Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satyanarayana V, M.Pharma., Ph.D, Principal investigator, Sipra Labs Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712568
- Sponsor's protocol ID
- SLL/RPR/1117/08
- Status last verified
- Oct 2012
- First submitted
- 19 Oct 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN OPEN LABEL, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, BIOEQUIVALENCE STUDY OF ROPINIROLE HYDROCHLORIDE CR 2mg TABLETS OF LUPIN LIMITED, INDIA, COMPARING WITH THAT OF REQUIP XL OF GLAXOSMITHKLINE RESEARCH TRIANGLE PARK, IN HEALTHY ADULT MALE SUBJECTS
- ClinicalTrials.gov ID
- NCT01712568
- Acronym / sponsor ID
- SLL/RPR/1117/08
- Conditions
- Pharmacokinetic Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lupin Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Oct 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.
Study subjects were screened and enrolled for the study. Subjects were housed in the clinical facility from not less than 12 hours pre-dose till at least 24 hours post-dose in each period. After maintaining at least 10 hours of overnight fast Test or Reference product was administered orally (as per the randomization schedule) to each subject with about 240 mL of water at ambient temperature in each period by trained study personnel.
The pre-dose (0.00 hours) blood sample was collected before dosing and post-dose samples were collected at 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours in each study period with a washout period of 7 days between the dosing of two periods. Subjects were continuously monitored for well being i.e., blood pressure, radial pulse and oral temperature before check-in, prior to drug administration and at regular intervals post dose in each period. The concentration of Ropinirole in plasma samples obtained from study subjects was determined using validated LC-MS/MS method. Pharmacokinetic and statistical analyses were performed on obtained drug concentration data, using appropriate software.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Test Product (Ropinirole), Drug: Reference Product (REQUIP )Drug: Ropinirole Single oral dose of Ropinirole hydrochloride CR 2mg Tablets under fasting conditions |
| Reference Product | Experimental | Drug: Test Product (Ropinirole), Drug: Reference Product (REQUIP )Drug: Ropinirole REQUIP XL Tablets (Ropinirole hydrochloride CR 2mg)commercial formulation under fasting conditions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the written informed consent form (ICF) duly signed by the volunteer.
- Healthy human male subjects between 18-45 years Weighing at least 50 kg and with a body mass index (BMI) of 18 kg/m2 and less than or equal to 25 kg/m2 (according to the formula of BMI = weight (kg)/[height (m)]2).
- Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 14 days prior to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- Light-, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex-smokers are defined as someone who completely stopped smoking for at least 3 months.
Key exclusion criteria (11 listed)
- History of hypersensitivity or idiosyncratic reactions to Ropinirole or any related products.
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse within past one year. IV. Moderate to heavy smoking (>10 cigarettes/day) or consumption of tobacco products.
- History of difficulty in swallowing VI. Clinically significant illness within 4 weeks before the start of the study VII. Asthma, urticaria or other allergic type reactions after taking any medication.
- Blood loss/donation of more than 350 mL within 3 months prior to study dosing or difficulty in donating blood.
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 |
|---|---|---|
| Test Product (Ropinirole)Also: Ropinirole HCl Tablets CR 2mgone Tablet at "0" hour | Drug | Reference Product, Test Product |
| Reference Product (REQUIP )Also: REQUIP XL Tabletsone Tablet at "0" hour | Drug | Reference Product, Test Product |
Primary outcome
Description of the pharmacokinetic (PK) profile for Ropinirole in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.
Time frame: Predose, 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours
1 secondary outcome
Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations and electrocardiograms
Time frame: From baseline day 0 through to post study Follow-up (maximum 20 days)
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 23 Oct 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.
Satyanarayana V, M.Pharma., Ph.D principal investigator
Sipra Labs Limited
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 Test Product (Ropinirole) and Reference Product (REQUIP ) in people with Pharmacokinetic Study, run by Lupin Ltd. 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 5 inclusion and 11 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 23 Oct 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?
Description of the pharmacokinetic (PK) profile for Ropinirole in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period. (time frame: Predose, 2.00, 3.00, 4.00, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 14.00, 16.00, 20.00, 24.00 and 30.00 hours). 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 23 Oct 2012.