Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

This study has been completed.
Sponsor:
Collaborator:
Genpharm ULC
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00647738
First received: March 30, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

The objective of this study was to investigate the bioequivalence of Genpharm's baclofen tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's baclofen 20 mg tablets are bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Baclofen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose Crossover Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2003
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Baclofen
Single-dose 20 mg immediate-release oral tablets
Active Comparator: 2 Drug: Baclofen
Single-dose 20 mg immediate-release oral tablet
Other Name: Lioresal®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects meeting all of the following criteria may be included in the study: Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject

Males aged from 18 to 55 years with a body mass index (BMI) greater than or equal to 19 and below 30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report

Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF (laboratory tests are presented in section 7.1.3)

Healthy according to the laboratory results and physical examination

Normal cardiovascular function according to ECG

Subjects should be light-, non- or ex-smokers

Exclusion Criteria:

Significant history of hypersensitivity to baclofen or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs

Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects

Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease

Presence or history of urologic disease

Presence or history of neuromuscular disease

Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease

Any clinically significant illness in the previous 28 days before day 1 of this study

Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)

Participation in another clinical trial in the previous 28 days before day 1 of this study

Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study

Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4)

Positive results to HIV, HBsAg or anti-HCV tests

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647738

Locations
Canada, Quebec
Algorithme Pharma
Montreal, Quebec, Canada, H4N 2Y8
Sponsors and Collaborators
Mylan Pharmaceuticals
Genpharm ULC
Investigators
Principal Investigator: Eric Sicard, MD Algorithme Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Elliot Offman, Director, Biopharmaceutics, Genpharm ULC
ClinicalTrials.gov Identifier: NCT00647738     History of Changes
Other Study ID Numbers: BCE-P3-022
Study First Received: March 30, 2008
Last Updated: March 31, 2008
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on September 29, 2014