A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.

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

Details

• Lead Sponsor: Labopharm Inc.
• Treatments: Acetaminophen; Tramadol

Criteria

Inclusion Criteria:

• Adult males or females aged 18-55 years inclusive with body mass index (BMI) between 18-30 kg/m2

• Healthy as determined by pre-study medical history, physical examination and 12-lead ECG

• Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator

• Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening

• Negative for drugs of abuse and alcohol at screening and admission

• Non-smokers for at least 3 months preceding screening

• If female, were not currently pregnant or breast feeding and were using medically acceptable methods of contraception and if male, were themselves and their female partners using medically acceptable methods of contraception

• Able and willing to give written informed consent.

Exclusion Criteria:

• Subjects who did not conform to the above inclusion criteria

• Female subjects who were pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception

• Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders

• Clinically relevant surgical history

• Clinically relevant family history

• History of relevant atopy

• History of relevant drug hypersensitivity

• History of alcoholism

• History of drug abuse

• Male subjects who consumed more than 21 units of alcohol a week and female subjects who consumed more than 14 units of alcohol a week

• Significant infection or known inflammatory process on screening

• Acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)

• Acute infection such as influenza at the time of screening or admission

• Use of prescription drugs within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor

• Use of over-the-counter medication excluding routine vitamins but including mega dose vitamin therapy within 14 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor

• Use of any investigational drug or participation in any clinical trial within 3 months of their first dosing

• Donation or receipt of any blood or blood products within the previous 3 months prior to first dosing

• Vegetarians, vegans or having medical or cultural dietary restrictions.

• Inability to communicate reliably with the Investigator.

• Subjects who were unlikely to co-operate with the requirements of the study