- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627847
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
September 27, 2012 updated by: Dr. Reddy's Laboratories Limited
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hyderabad, Andhra Pradesh
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Ameerpet, Hyderabad, Andhra Pradesh, India, 500 038
- GVK Biosciences Pvt. Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ropinirole
Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited
|
Other Names:
|
Active Comparator: Requip
Requip XL Tablets 2 mg of Glaxosmithkline, USA
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 22, 2012
First Submitted That Met QC Criteria
June 22, 2012
First Posted (Estimate)
June 26, 2012
Study Record Updates
Last Update Posted (Estimate)
September 28, 2012
Last Update Submitted That Met QC Criteria
September 27, 2012
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 035-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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