NCT00829504

Brief Summary

The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 18, 2009

Completed
Last Updated

September 11, 2009

Status Verified

September 1, 2009

Enrollment Period

Same day

First QC Date

January 26, 2009

Results QC Date

July 6, 2009

Last Update Submit

September 1, 2009

Conditions

Healthy

Keywords

BioequivalenceHealthy Subjects

Outcome Measures

Primary Outcomes (3)

  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

    Bioequivalence based on Cmax.

    Blood samples collected over a 24 hour period.

  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

    Bioequivalence based on AUC0-t.

    Blood samples collected over a 24 hour period.

  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

    Bioequivalence based on AUC0-inf.

    Blood samples collected over a 24 hour period.

Study Arms (2)

1

EXPERIMENTAL
Drug: Ropinirole HCl 0.25 mg Tablets

2

ACTIVE COMPARATOR
Drug: Requip® 0.25 mg Tablets

Interventions

Ropinirole HCl 0.25 mg TabletsDRUG

1 x 0.25 mg

1
Requip® 0.25 mg TabletsDRUG

1 x 0.25 mg

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males and/or females who were between 18 and 45 years old

You may not qualify if:

  • If female, pregnant, lactating or likely to become pregnant during this 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 of 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, arrythmia, tachycardia, seizure disorder or glaucoma.
  • Presence of gastrointestinal disease or history of malabsorption within the last year.
  • History of psychiatric disorders occuring 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 the past 14 days prior to dosing.
  • Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
  • Positive test results for drugs of abuse at screening.
  • Tobacco user within 90 days of the first study date.
  • Unable, or unwilling to tolerate multiple venipunctures.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novum Pharmaceutical Research Services

Houston, Texas, 77042, United States

Location

MeSH Terms

Interventions

ropinirole

Results Point of Contact

Title
Manager, Biopharmaceutics
Organization
TEVA Pharmaceuticals, USA
clinicaltrialqueries@tevausa.com
1-866-384-5525

Study Officials

  • Soran Hong, M.D.

    Novum Pharmaceuticals Research Services

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

October 1, 2004

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

September 11, 2009

Results First Posted

August 18, 2009

Record last verified: 2009-09

Locations

US(1)