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

Yungjin Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Tramadol HCI/Acetaminophen

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01880125

YJ4-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group A

Other group

Description:

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

Treatment:

Drug: Tramadol HCI/Acetaminophen

Group B

Other group

Description:

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

Treatment:

Drug: Tramadol HCI/Acetaminophen