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Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01074463
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : April 30, 2010
Last Update Posted : April 30, 2010
Sponsor:
Information provided by:

February 22, 2010
February 24, 2010
April 8, 2010
April 30, 2010
April 30, 2010
February 2005
March 2005   (Final data collection date for primary outcome measure)
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on Cmax.
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on AUC0-t.
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 48 hour period. ]
    Bioequivalence based on AUC0-inf.
  • Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 48 hour period. ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 48 hour period. ]
Complete list of historical versions of study NCT01074463 on ClinicalTrials.gov Archive Site
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Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions
A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Non-Fasting Conditions
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Pramipexole Dihydrochloride
    0.25 mg Tablet
  • Drug: Pramipexole Dihydrochloride
    0.25 mg Tablet
    Other Name: Mirapex®
  • Experimental: 1
    Pramipexole Dihydrochloride 0.25 mg Tablets
    Intervention: Drug: Pramipexole Dihydrochloride
  • Active Comparator: 2
    Mirapex® 0.25 mg Tablets
    Intervention: Drug: Pramipexole Dihydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2005
March 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All volunteers selected for this study will be healthy men and women 18 to 45 years of age, inclusive.
  • The weight range will not exceed + 20% for height and body frame as per "Desirable Weights for Adults - 1983 Metropolitan Height and Weight Table"
  • Each volunteer will complete the screening process within 28 days prior to Period 1 dosing.
  • Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
  • If female: and of child bearing potential is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), is postmenopausal for at least 1 year, or is surgically sterile.

Exclusion Criteria:

  • Volunteers with a recent history of drug or alcohol addiction or abuse.
  • Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
  • Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Volunteers demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
  • Volunteers demonstrating a positive drug abuse screen when screened for this study.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are currently breastfeeding.
  • Volunteers with a history of allergic response(s) to pramipexole or related drugs.
  • Volunteers with a history of clinically significant allergies including drug allergies.
  • Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Volunteers who currently use tobacco products.
  • Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  • Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for 4 weeks after completing the study.
  • Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
  • Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
  • Volunteer who report taking any systemic prescription medication in the 14 days prior to Period I dosing. Diltiazem (Cardizem®), triamterene (Dyrenium®), verapamil (Calan®, Covera-HS®), quinidine, and quinine are prohibited throughout the entire study.
  • Volunteers using OTC medication 7 days prior to dosing including vitamins, cough and cold preparations. Cimetidine (Tagamet®), ranitidine (Zantac®), probenecid (Pro-Bionate®), and any OTC antihistamine products (such as diphenhydramine, chlorpheniramine) are absolutely prohibited throughout the entire study.
  • Volunteers who consume food containing poppy seeds in the 48 hours before dosing of each period.
  • Volunteers who consume grapefruit or related products 14 days prior to Period I dosing.
  • Female volunteers who report the use of oral contraceptives or injectable contraceptives.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01074463
R04-1203
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Teva Pharmaceuticals USA
Not Provided
Principal Investigator: James D Carlson, Pharm. D PRACS Institute, Ltd.
Teva Pharmaceuticals USA
April 2010

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