Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions

NCT01074450 | Completed Phase 1 Results

• 1 other identifier: R04-1202
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

  Bioequivalence based on Cmax.

  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)

  Bioequivalence based on AUC0-t.

  Blood samples collected over a 48 hour period.

• AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

  Bioequivalence based on AUC0-inf.

  Blood samples collected over a 48 hour period.

Study Arms (2)

1

EXPERIMENTAL

Pramipexole Dihydrochloride 0.25 mg Tablets

Drug: Pramipexole Dihydrochloride

2

ACTIVE COMPARATOR

Mirapex® 0.25 mg Tablets

Drug: Pramipexole Dihydrochloride

Interventions

Pramipexole Dihydrochloride DRUG

0.25 mg Tablet

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

Pramipexole

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Associate Director, Biopharmaceutics
• Organization: TEVA Pharmaceuticals, USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D Carlson, Pharm. D

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2005
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: April 30, 2010
• Results First Posted: April 30, 2010

Record last verified: 2010-04

Locations

US (1)