Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
Condition: Healthy
Intervention: Pramipexole Dihydrochloride; Pramipexole Dihydrochloride
Intervention description: 0.25 mg Tablet; 0.25 mg Tablet
Intervention MeSH terms: Pramipexole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      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.
    

Eligibility criteria:

        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.