Clinical trial NCT01074450: Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

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.

Primary outcomes:
measure: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
timeFrame: Blood samples collected over a 48 hour period.
measure: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
timeFrame: Blood samples collected over a 48 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: James D Carlson, Pharm. D
role: PRINCIPAL_INVESTIGATOR
References: