Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions

• Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 48 hour period. ] [ Designated as safety issue: No ]
  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. ] [ Designated as safety issue: No ]
  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. ] [ Designated as safety issue: No ]
  Bioequivalence based on AUC0-inf.

• Cmax (maximum observed concentration of drug substance in plasma) [ Time Frame: Blood samples collected over a 48 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 48 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 48 hour period. ] [ Designated as safety issue: No ]

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 fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

• 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

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 Weight for Adults - 1983 Metropolitan Height and Weight Table.
• Each volunteer will complete the screening process within 28 days prior to Period I 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 investigator).
• 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 150mL 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 1 dosing.
• Volunteers who report taking any systemic prescription medications 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®), 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.