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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Tramadol Contramid Once A Day

Group Type EXPERIMENTAL

Tramadol Contramid OAD

Intervention Type DRUG

1 Tramadol Contramid OAD 200 mg tablet as a single dose

2 Zytram (R)

Group Type ACTIVE_COMPARATOR

Zytram

Intervention Type DRUG

1 Zytram 200 mg tablet as a single dose

Interventions

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Tramadol Contramid OAD

1 Tramadol Contramid OAD 200 mg tablet as a single dose

Intervention Type DRUG

Zytram

1 Zytram 200 mg tablet as a single dose

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes