Clinical trial NCT01880125: Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination
Official title: Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Tramadol
Acetaminophen
Pharmacokinetics
Sustained release
Immediate release
Lead sponsor: Yungjin Pharm. Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chonbuk National University Hospital
First posted: 2013-06-18
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state
2. Subjects: Healthy subject
3. Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.

Detailed description: This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.

Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 20 and 45 years
* Subjects weighed ≥ 45 kg and were within 20% of their ideal body weight
* No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test

Exclusion Criteria:

* Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen
* Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases
* Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study
* Systolic blood pressure (SBP) ≥ 160 mmHg or ≤ 100 mmHg or diastolic blood pressure (DBP) ≥ 95 mmHg or ≤ 60 mmHg
* Any surgical or medical conditions that could affect drug absorption

Primary outcomes:
measure: Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
timeFrame: 0 to 36 hour
Secondary outcomes:
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
measure: Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
timeFrame: 0 to 36 hour
Other outcomes:
Locations:
Study officials:
References:
citation: Im YJ, Jeon JY, Kim EY, Kim Y, Oh DJ, Yoo JS, Shin DH, Chae SW, Kim MG. An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects. Clin Ther. 2015 Feb 1;37(2):376-89. doi: 10.1016/j.clinthera.2014.12.007. Epub 2015 Jan 22.