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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01627847
First received: June 22, 2012
Last updated: September 27, 2012
Last verified: January 2010

June 22, 2012
September 27, 2012
October 2009
October 2009   (final data collection date for 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01627847 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Ropinirole
Other Name: Requip
  • Experimental: Ropinirole
    Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Ropinirole
  • Active Comparator: Requip
    Requip XL Tablets 2 mg of Glaxosmithkline, USA
    Intervention: Drug: Ropinirole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
November 2009
October 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01627847
035-09
No
Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Dr. Naba Kr Talukdar, MD GVK Biosciences Pvt. Ltd.
Dr. Reddy's Laboratories Limited
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP