A Pharmacokinetic Study to Evaluate the Dose-Proportionality of Tramadol (ULTRAM) Extended-Release (ER) in Healthy Participants
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Tramodol Extended-Release (ER) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum concentration (Cmax) of TramadolTime to reach maximum concentration (tmax) of Tramadol Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUC[last]) Area under the plasma concentration-time curve from time 0 to infinite time (AUC[infinity]) Elimination half-life period (t1/2) associated with the terminal slope (Lambda z) Terminal slope (Lambda z)
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Overland Park, Kansas, United States
Additional Information
Starting date: July 2011
Last updated: February 26, 2013
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