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Completed

NCT Number: NCT01800682

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramodol Extended-Release (ER)

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2013
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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