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

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

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.

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 Tramadol

Time 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.

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

Overland Park, Kansas, United States

Starting date: July 2011
Last updated: February 26, 2013