The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00830219
First received: January 26, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride) 0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.


Condition Intervention Phase
Healthy
Drug: Ropinirole HCl 0.25 mg Tablets
Drug: Requip® 0.25 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: November 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Ropinirole HCl 0.25 mg Tablets
1 x 0.25 mg, single dose fed
Active Comparator: 2 Drug: Requip® 0.25 mg Tablets
1 x 0.25 mg, single dose fed

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

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

Inclusion Criteria:

  • Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of 19-30 kg/m² inclusive and weighing at least 120 lbs.
  • Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at least 60 b.p.m.
  • Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
  • Signed and dated informed consent form, which meets all criteria of current FDA regulations.
  • If female and of child bearing potential, subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom with spermicide, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected or implanted hormonal contraceptives within 180 days of dosing will not be allowed to participate.

Exclusion Criteria:

  • If female, pregnant, lactating, or likely to become pregnant during the study.
  • History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g. Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study.
  • History of dizziness, lightheadedness or fainting upon standing.
  • Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, hyper/hypotension, arrhythmia, tachycardia, seizure disorder or glaucoma.
  • Presence of gastrointestinal disease or history of malabsorption within the last year.
  • History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
  • Presence of a medical condition requiring regular treatment with prescription drugs.
  • Use of pharmacologic agents known to significantly induce or inhibit drug metabolizing enzymes within 30 days prior to dosing.
  • Receipt of any drug as part of a research study within 30 days prior to dosing.
  • Drug or alcohol addiction requiring treatment in the past 12 months.
  • Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
  • Positive test results for HIC, Hepatitis B surface antigen or Hepatitis C antibody.
  • Positive test results for drugs of abuse at screening.
  • Positive serum pregnancy test.
  • Tobacco user within 90 days of the first study dose.
  • Unable, or unwilling to tolerate multiple venipunctures.
  • Difficulty fasting or eating the standard meals that will be provided.
  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: NCT00830219

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00830219     History of Changes
Other Study ID Numbers: 10436009
Study First Received: January 26, 2009
Results First Received: July 6, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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

ClinicalTrials.gov processed this record on August 20, 2014