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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Tramadol Contramid OAD; Drug: Zytram

• Registration Number: NCT00911742
• Lead Sponsor: Labopharm Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2009-04-08
• Results First Submitted: 2009-04-08
• Study First Submitted QC: 2009-06-01
• Results First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-02
• Results First Posted: 2009-06-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 Tramadol Contramid Once A Day	Tramadol Contramid OAD	-
2 Zytram (R)	Zytram	-

Primary Outcome Measures

Name	Time	Method
AUC (0-∞)	48 hours	The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0-t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R'2 (coefficient of determination). The units are ng.h/mL.; h=hours
Cmax	48 hours	Maximum plasma concentration
AUC(0-t)	48 hours	Area under the plasma concentration versus time curve to the last measured concentration.; h=hour

Secondary Outcome Measures

Name	Time	Method
t1/2	48 hours	Apparent terminal elimination half-life
Tmax	48 hours	Time to maximum plasma concentration