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

Pain Clinical Trial

Official title:

Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg OAD Formulation Versus Zytram® 200 mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911742
• Other study ID #: MDT1-012
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2009
• Last updated: April 24, 2012
• Start date: February 2004
• Est. completion date: March 2004

Study information

• Verified date: April 2012
• Source: Labopharm Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Tramadol Contramid OAD
1 Tramadol Contramid OAD 200 mg tablet as a single dose
• Zytram
1 Zytram 200 mg tablet as a single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Labopharm Inc.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-t)	Area under the plasma concentration versus time curve to the last measured concentration.; h=hour	48 hours	No
Primary	AUC (0-8)	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	No
Primary	Cmax	Maximum plasma concentration	48 hours	No
Secondary	t1/2	Apparent terminal elimination half-life	48 hours	No
Secondary	Tmax	Time to maximum plasma concentration	48 hours	No