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

NCT00911742 | Completed Phase 1 Results

• 1 other identifier: MDT1-012
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• AUC(0-t)

  Area under the plasma concentration versus time curve to the last measured concentration. h=hour

  48 hours

• AUC (0-∞)

  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

  48 hours

• Cmax

  Maximum plasma concentration

  48 hours

Secondary Outcomes (2)

• t1/2

  48 hours

• Tmax

  48 hours

Study Arms (2)

1 Tramadol Contramid Once A Day

EXPERIMENTAL

Drug: Tramadol Contramid OAD

2 Zytram (R)

ACTIVE COMPARATOR

Drug: Zytram

Interventions

Tramadol Contramid OAD DRUG

1 Tramadol Contramid OAD 200 mg tablet as a single dose

1 Tramadol Contramid Once A Day

Zytram DRUG

1 Zytram 200 mg tablet as a single dose

2 Zytram (R)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Labopharm Inc.: lead

Related Publications (1)

• Hernandez-Lopez C, Martinez-Farnos L, Karhu D, Perez-Campos T, Rovira S, Encina G. Comparative bioavailability between two Tramadol once-daily oral formulations. Methods Find Exp Clin Pharmacol. 2006 Jul-Aug;28(6):373-8. doi: 10.1358/mf.2006.28.6.1007674.

  PMID: 16894407 RESULT

MeSH Terms

Conditions

Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: June 2, 2009
• Study Start: February 1, 2004
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: April 27, 2012
• Results First Posted: June 2, 2009

Record last verified: 2012-04