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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01800682
First received: February 26, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Tramodol Extended-Release (ER)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The Cmax is the maximum plasma concentration.

  • 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 ] [ Designated as safety issue: No ]
    The Tmax is time to reach the maximum plasma concentration.

  • 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 ] [ Designated as safety issue: No ]
    The AUC(last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: - 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 Name: - 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 Name: - Ultram

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800682

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01800682     History of Changes
Other Study ID Numbers: CR018658, TRAM-PAI-1001
Study First Received: February 26, 2013
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy
Tramodol
Ultram

Additional relevant MeSH terms:
Tramadol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 28, 2014