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
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Zaldiar®Drug: Ultracet®, multiple doses, (fed & fasting)
- Registration Number
- NCT00973232
- Lead Sponsor
- Labopharm Inc.
- Brief 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.
- Detailed Description
* To compare the single (Part A) and multiple dose (Part B) pharmacokinetic profiles and bioavailability of DDS-06C tablets with the immediate-release tablet reference products Zaldiar® and Ultracet®.
* To assess the effect of food on the pharmacokinetic profile of DDS-06C tablets following administration of a single oral dose.
* To monitor and record all adverse events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part B, Arm E Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions - Part A, Arm D Ultracet® - Part A, Arm A DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl) - Part A, Arm B DDS-06C (650 mg acetaminophen and 75 mg tramadol) - Part A, Arm C Zaldiar® - Part B, Arm G Ultracet®, multiple doses, (fed & fasting) -
- Primary Outcome Measures
Name Time Method Rate and extent of exposure 0 to 36 hours post dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guy's Drug Research Unit, Quintiles Ltd
🇬🇧London, United Kingdom