Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State
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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 |
- 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 |
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 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 |
Additional relevant MeSH terms:
|
Baclofen GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013