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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yungjin Pharm. Co., Ltd.
• Collaborator: Chonbuk National University Hospital
• Treatments: Acetaminophen; Tramadol

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