- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00834912
Study of Two Tramadol Contramid® OAD 300 mg Controlled-Release Tablets From Two Different Manufacturing Sites Following a 300 mg Dose in Healthy Subjects Under Fasting and Fed Conditions
April 25, 2012 updated by: Labopharm Inc.
The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release tablet under fasting conditions.
The effect of food on the to-be-marketed formulation was also assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, non-smoker, ≥18 and ≤55 years of age.
- Capable of consent.
- Body Mass Index (BMI) ≥19.0 and <30.0 kg/m2.
Exclusion Criteria:
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- Electrocardiogram (ECG) abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 beats per minute [bpm]) at screening.
- History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
- Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to tramadol or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (Selective serotonin reuptake inhibitors [SSRIs]), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
- Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 3 months preceding drug administration.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- 50 mL to 499 mL of whole blood within 30 days,
- more than 499 mL of whole blood within 56 days prior to drug administration.
- Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
- History or presence of substance addiction.
- History of anaphylactoid reactions to codeine and other opioids.
- History of respiratory depression.
- History of increased intracranial pressure or head injury.
- History or presence of asthma, chronic obstructive pulmonary disease or other pulmonary condition that may predispose to hypoventilation.
- Opioid consumption in the 3 months preceding drug administration or history of drug dependence to any opioids.
- Positive urine pregnancy test at screening.
- Breast-feeding subject.
- Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception are:
- intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
- condom or diaphragm + spermicide;
- hormonal contraceptives (starting at least 4 weeks prior to study drug administration).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1: Tramadol HCl (Confab Laboratories) fasting
|
1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition.
Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule.
Results are presented per treatment group overall.
|
EXPERIMENTAL: 2: Tramadol HCl (Confab Laboratories) fed
|
1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition.
Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule.
Results are presented per treatment group overall.
1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition.
Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule.
Results are presented per treatment group overall.
|
EXPERIMENTAL: 3: Tramadol HCl (Trillium Healthcare) fasting
|
1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fed condition.
Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule.
Results are presented per treatment group overall.
1x300mg Tramadol Hydrochloride (HCl) tablet (Trillium Healthcare) fasting condition.
Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule.
Results are presented per treatment group overall.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC(0-t)
Time Frame: 48 hours
|
Area under the plasma concentration (AUC) versus time curve to the last measurable concentration.
|
48 hours
|
AUC(0-∞)
Time Frame: 48 hours
|
The area under the plasma concentration (AUC) 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
Time Frame: 48 hours
|
Maximum plasma concentration (Cmax)
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: 48 hours
|
Time to maximum plasma concentration (Tmax)
|
48 hours
|
t1/2
Time Frame: 48 hours
|
Apparent terminal elimination half-life (t1/2)
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (ACTUAL)
April 1, 2006
Study Completion (ACTUAL)
April 1, 2006
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
February 2, 2009
First Posted (ESTIMATE)
February 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 30, 2012
Last Update Submitted That Met QC Criteria
April 25, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT1-016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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