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Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition

Sponsor
Dr. Reddy's Laboratories Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT01627847
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
1
Duration (Months)
47.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ropinirole

Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited

Drug: Ropinirole
Other Names:
  • Requip

    		•
    Active Comparator: Requip

    Requip XL Tablets 2 mg of Glaxosmithkline, USA

    Drug: Ropinirole
    Other Names:
  • Requip

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under curve(AUC) [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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Healthy human subjects aged between 18 and 45 years (including both).

    2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs.

    3. Subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests.

    4. Subjects having normal 12-lead electrocardiogram (ECG).

    5. Subjects having normal chest X-Ray (PIA view).

    6. Subjects able to communicate effectively.

    7. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.

    8. Female subjects who are postmenopausal or surgically sterile.

    9. 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:

    1. Subjects having contraindications or hypersensitivity to ropinirole or domperidone or related group of drugs.

    2. History or presence of any medical condition or disease according to the opinion of the physician.

    3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.

    4. History or presence of significant alcoholism or drug abuse in the past one year.

    5. History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products).

    6. Difficulty with donating blood.

    7. Difficulty in swallowing solids like tablets or capsules.

    8. Systolic blood pressure less than 110mm Hg or more than 140 mm Hg.

    9. Diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.

    10. Pulse rate less than 50 beats/minute or more than 100 beats/minute.

    11. Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing.

    12. Major illness during 3 months before screening.

    13. Participation in a drug research study within past 3 months.

    14. Donation of blood in the past 3 months before screening.

    15. Female subjects demonstrating a positive pregnancy screen.

    16. Female subjects who are currently breast-feeding.

    17. Female subjects with child bearing potential using prohibited contraceptive method (Oral, Injectable or Implantable hormonal agents).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GVK Biosciences Pvt. Ltd Ameerpet Hyderabad, Andhra Pradesh India 500 038

    Sponsors and Collaborators

    • Dr. Reddy's Laboratories Limited

    Investigators

    • Principal Investigator: Dr. Naba Kr Talukdar, MD, GVK Biosciences Pvt. Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Reddy's Laboratories Limited
    ClinicalTrials.gov Identifier:
    NCT01627847
    Other Study ID Numbers:
    • 035-09
    First Posted:
    Jun 26, 2012
    Last Update Posted:
    Sep 28, 2012
    Last Verified:
    Jan 1, 2010
    Keywords provided by Dr. Reddy's Laboratories Limited
    Bioequivalence
    Ropinirole Hydrochloride
    crossover
    Additional relevant MeSH terms:
    Malnutrition
    Ropinirole

    Study Results

    No Results Posted as of Sep 28, 2012