NCT01800682

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

February 26, 2013

Last Update Submit

February 26, 2013

Conditions

Healthy

Keywords

HealthyTramodolUltram

Outcome Measures

Primary Outcomes (6)

  • Maximum concentration (Cmax) of Tramadol

    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

    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])

    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])

    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)

    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)

    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

Study Arms (3)

Tramodol Extended-release (ER), 25 milligram (mg)

EXPERIMENTAL

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, 50 mg

EXPERIMENTAL

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, 100 mg

EXPERIMENTAL

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)

Interventions

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).

Also known as: - Ultram
Tramodol ER, 100 mgTramodol ER, 50 mgTramodol Extended-release (ER), 25 milligram (mg)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

February 28, 2013

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)