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

Labopharm

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Zytram; Drug: Tramadol Contramid OAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911742

MDT1-012

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

1 Tramadol Contramid Once A Day

Experimental group

Treatment:

Drug: Tramadol Contramid OAD

2 Zytram (R)

Active Comparator group

Treatment:

Drug: Zytram