Phase 1
N=26
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
Bottom Line
View on ClinicalTrials.gov: NCT00911742 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: AUC(0-t) — 5886; 4761 ng.h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tramadol Contramid OAD (Drug); Zytram (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Labopharm Inc.
- Primary completion
- Mar 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC(0-t) |
5886; 4761 | — |
| PRIMARY AUC (0-∞) |
6112; 5638 | — |
| PRIMARY Cmax |
270; 219 | — |
| SECONDARY t1/2 |
7.41; 14.92 | — |
| SECONDARY Tmax |
9.0; 4.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00911742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.