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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01627834
First received: June 22, 2012
Last updated: September 27, 2012
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Ropinirole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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) 2 mg ER Tablets of Glaxosmithkline, USA, in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropinirole
Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited
Drug: Ropinirole
Other Name: Requip
Active Comparator: Requip
Requip XL Tablets 2 mg of Glaxosmithkline, USA
Drug: Ropinirole
Other Name: Requip

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) 2 mg ER Tablets of Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fasting condition.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627834

Locations
India
GVK Biosciences Pvt. Ltd
Ameerpet, Hyderabad, India, 500 038
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Dr. Naba Kr Talukdar, MD GVK Biosciences Pvt. Ltd.
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01627834     History of Changes
Other Study ID Numbers: 034-09
Study First Received: June 22, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Ropinirole Hydrochloride
crossover

Additional relevant MeSH terms:
Ropinirole
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014