Status:
COMPLETED
Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination
Lead Sponsor:
Yungjin Pharm. Co., Ltd.
Collaborating Sponsors:
Chonbuk National University Hospital
Conditions:
Pain
Eligibility:
MALE
20-45 years
Phase:
PHASE1
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 formulatio...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01880125
Start Date
January 1 2012
End Date
May 1 2012
Last Update
May 5 2021
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