Status:
COMPLETED
Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg
Lead Sponsor:
Labopharm Inc.
Conditions:
Pain
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to compare the pharmacokinetic profile to establish the better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg, Labopharm) and its bioav...
Eligibility Criteria
Inclusion
- Healthy subjects of either gender
- Age between 18 and 45 years
- Body mass index between 19 and 27kg/m2
- Normal medical history
- Normal or no clinically significant physical examination findings
- Normal or no clinically significant findings in analytical tests
- Negative hepatitis B, hepatitis C or HIV serology
- Negative drugs of abuse in urine
- Negative pregnancy test in females
- The subject understands and accepts the study procedures and grants in writing his/her informed consent
Exclusion
- Did not fulfill the inclusion criteria
- Organic disorders or underwent major surgery, within 90 days before study screening
- Psychiatric history
- Alcohol drink intake greater than 30gr/day
- Cigarette smoking greater than 10 cigarettes/day
- Excessive consumption of food or beverages containing xanthines (more than five units of coffee, tea or cola per day)
- Medical treatment within 30 days before screening, and/or any medication 7 days before starting the study
- Participation in other clinical study or donate blood within 90 days before starting this study
- Antecedents of gastric, hepatic, renal and other kind of disorder that could affect ADME (absorption, distribution, metabolism or excretion of the study drug)
- Hepatitis B, hepatitis C or HIV positive serology
- Pregnant or breastfeeding
- Clinically relevant hypersensitivities (in particular to drugs)
- Woman taking oral contraceptive drugs
- Incapable of communicating and cooperating with investigators
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00911742
Start Date
February 1 2004
End Date
March 1 2004
Last Update
April 27 2012
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