A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramadol (ULTRAM) Extended-Release (ER) in Healthy Participants

February 26, 2013 updated by: Janssen Research & Development, LLC

A Single-Dose, Open-Label, Randomized, Crossover Dose-Proportionality Study to Evaluate the Effect of Dose on the Pharmacokinetics of 25, 50, and 100 mg ULTRAM ER Under Fasted Conditions in Healthy Adult Subjects

The purpose of this study is to evaluate the dose proportionality of the pharmacokinetics (explores what the body does to the drug) of tramadol in healthy adult participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (all people know the identity of the intervention), single-center, randomized (study drug assigned by chance), and 3-way crossover (method used to switch participants from one study group to another in a clinical trial) study of tramadol extended-release (ER). All participants will be randomly assigned to 1 of 6 possible treatment sequences of tramadol. The study consists of 3 parts: Screening (within 20 days before study commences on Day -1); Open-label treatment (consisting of 3 single-dose treatment periods separated with washout period of 4-14 days, and dosing will be under fasting conditions on Day 1 in each treatment period); and Follow-up (up to 48-hour blood sample collection on Day 3 of Period 3). The duration of study is anticipated to be 6-8 weeks per participant. Participants' safety will be monitored throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females with negative pregnancy test at Screening and on Day -1 of each treatment period
  • Postmenopausal Females (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control
  • Body mass index (BMI; weight in kilogram [kg] divided by height in square meter [m^2]) from 18 to 30 kilogram per square meter (kg/m^2), and body weight not less than 50 kg
  • Blood pressure (after the participant is supine for 5 minutes - average of a minimum of 2 readings taken at intervals of at least 1 minute) between 90 and 140 millimeter of mercury (mmHg) systolic (top number in blood pressure, pressure during active contraction of the heart), and no higher than 90 mmHg diastolic (lower number in blood pressure reading pertaining to resting or relaxation phase of heart beat)
  • Non-Smoker

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospasmic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for laboratory tests at Screening
  • Clinically significant abnormal physical examination, vital signs or electrocardiogram at Screening
  • Use of any prescription or non-prescription medication (including monoamine oxidase inhibitors, laxatives, vitamins, and herbal supplements), except for acetaminophen, oral contraceptives and hormonal replacement therapy within 30 days before the first dose of the study drug is scheduled
  • History of drug or alcohol abuse within the past 5 years

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tramodol Extended-release (ER), 25 milligram (mg)
Tramodol ER, 25 mg tablets will be administered orally once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Drug: Tramodol Extended-Release (ER)
Tramodol ER, will be administered orally as either 25, 50 or 100 milligram tablet, once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Other Names:
  • - Ultram
Experimental: Tramodol ER, 50 mg
Tramodol ER, 50 mg tablets will be administered orally once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Drug: Tramodol Extended-Release (ER)
Tramodol ER, will be administered orally as either 25, 50 or 100 milligram tablet, once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Other Names:
  • - Ultram
Experimental: Tramodol ER, 100 mg
Tramodol ER, 100 mg tablets will be administered orally once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Drug: Tramodol Extended-Release (ER)
Tramodol ER, will be administered orally as either 25, 50 or 100 milligram tablet, once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
Other Names:
  • - Ultram

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum concentration (Cmax) of Tramadol
Time Frame: Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
The Cmax is the maximum plasma concentration.
Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Time to reach maximum concentration (tmax) of Tramadol
Time Frame: Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
The Tmax is time to reach the maximum plasma concentration.
Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUC[last])
Time Frame: Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
The AUC(last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Area under the plasma concentration-time curve from time 0 to infinite time (AUC[infinity])
Time Frame: Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
The AUC(infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.
Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Elimination half-life period (t1/2) associated with the terminal slope (Lambda z)
Time Frame: Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Terminal slope (Lambda z)
Time Frame: Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment
Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Predose and at 0, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 15, 16, 20, 24, 36, and 48 hours post dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR018658
  • TRAM-PAI-1001

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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