Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State
Information source: Mylan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Baclofen (Drug); Baclofen (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s):
Eric Sicard, MD, Principal Investigator, Affiliation: Algorithme Pharma Inc
Summary
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.
Clinical Details
Official title: Single Dose Crossover Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Algorithme Pharma, Montreal, Quebec H4N 2Y8, Canada
Additional Information
Mylan Pharmaceuticals Inc. - Clinical Trial Results Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use Recalls, Market Withdrawals and Safety Alerts FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: October 2003
Ending date: November 2003
Last updated: March 31, 2008
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