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

NCT00647738 | Completed Phase 1 DMC

• 1 other identifier: BCE-P3-022
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  Within 30 days

Study Arms (2)

1

EXPERIMENTAL

Drug: Baclofen

2

ACTIVE COMPARATOR

Drug: Baclofen

Interventions

Baclofen DRUG

Single-dose 20 mg immediate-release oral tablets

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead
• Genpharm ULC: collaborator

Study Sites (1)

Algorithme Pharma

Montreal, Quebec, H4N 2Y8, Canada

Location

Related Links

• 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

MeSH Terms

Interventions

Baclofen

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Eric Sicard, MD

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 30, 2008
• First Posted: April 1, 2008
• Study Start: October 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CA (1)