Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination

NCT ID: NCT01880125

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

Period 1: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state

Group Type: OTHER

Tramadol HCI/Acetaminophen

Intervention Type: DRUG

Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.

Group B

Period 1: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state

Group Type: OTHER

Tramadol HCI/Acetaminophen

Intervention Type: DRUG

Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.

Interventions

Tramadol HCI/Acetaminophen

Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.

Intervention Type: DRUG

Other Intervention Names

ULTRACET immediate release tablet; YJAT sustained release tablet

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: collaborator

Yungjin Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 25618318 (View on PubMed)

Other Identifiers

YJ4-101

Identifier Type: -

Identifier Source: org_study_id