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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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 bioavailability in relation with the commercialised reference (Zytram® tablets of 200 mg, Zambon), single dose administered.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Labopharm Inc.
• Treatments: Tramadol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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