Pramipexole Dihydrochloride 0.25 mg Tablets Under Non-Fasting Conditions

Launched by TEVA PHARMACEUTICALS USA · Feb 23, 2010

Keywords

ClinConnect Summary

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Gender

ALL

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 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.